gmp & quality assurance b. introduction gmp ensures that quality is built into the organization...
TRANSCRIPT
GMP amp Quality GMP amp Quality AssuranceAssurance
GMP amp Quality GMP amp Quality AssuranceAssurance
BB
Introduction
bull GMP ensures that quality is built into the organization amp processes involved in manufacture
bull GMP covers all aspects of manufacture including collection transportation processing storage QC amp delivery of the finished product
GMPbull Part of QA which
ensures that products are consistently produced amp controlled to the quality standards appropriate to their use
bull GMP is an integral part of QA
QA GMP amp QC inter-relationship
QA It is the sum total of the organized
arrangements with the objective of ensuring that products will be of the
quality required for their intended use
QA GMP amp QC inter-relationship
GMP
Is that part of QA aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use
QA GMP amp QC inter-relationship
QC
Part of GMP concerned with sampling
specification amp testing documentation amp release procedures which ensure
that the necessary amp relevant tests are
performed amp the product is released for use only after ascertaining itrsquos
quality
QC amp QAbull Part of GMP which is
concerned with sampling
specifications testing and with in the organization documentation and release procedures which ensure that the necessary amp relevant tests are carried out
bull QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use
QC amp QAbull Operational
laboratory techniques amp activities used to fulfill the requirement of Quality
bull All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Introduction
bull GMP ensures that quality is built into the organization amp processes involved in manufacture
bull GMP covers all aspects of manufacture including collection transportation processing storage QC amp delivery of the finished product
GMPbull Part of QA which
ensures that products are consistently produced amp controlled to the quality standards appropriate to their use
bull GMP is an integral part of QA
QA GMP amp QC inter-relationship
QA It is the sum total of the organized
arrangements with the objective of ensuring that products will be of the
quality required for their intended use
QA GMP amp QC inter-relationship
GMP
Is that part of QA aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use
QA GMP amp QC inter-relationship
QC
Part of GMP concerned with sampling
specification amp testing documentation amp release procedures which ensure
that the necessary amp relevant tests are
performed amp the product is released for use only after ascertaining itrsquos
quality
QC amp QAbull Part of GMP which is
concerned with sampling
specifications testing and with in the organization documentation and release procedures which ensure that the necessary amp relevant tests are carried out
bull QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use
QC amp QAbull Operational
laboratory techniques amp activities used to fulfill the requirement of Quality
bull All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
GMPbull Part of QA which
ensures that products are consistently produced amp controlled to the quality standards appropriate to their use
bull GMP is an integral part of QA
QA GMP amp QC inter-relationship
QA It is the sum total of the organized
arrangements with the objective of ensuring that products will be of the
quality required for their intended use
QA GMP amp QC inter-relationship
GMP
Is that part of QA aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use
QA GMP amp QC inter-relationship
QC
Part of GMP concerned with sampling
specification amp testing documentation amp release procedures which ensure
that the necessary amp relevant tests are
performed amp the product is released for use only after ascertaining itrsquos
quality
QC amp QAbull Part of GMP which is
concerned with sampling
specifications testing and with in the organization documentation and release procedures which ensure that the necessary amp relevant tests are carried out
bull QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use
QC amp QAbull Operational
laboratory techniques amp activities used to fulfill the requirement of Quality
bull All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QA GMP amp QC inter-relationship
QA It is the sum total of the organized
arrangements with the objective of ensuring that products will be of the
quality required for their intended use
QA GMP amp QC inter-relationship
GMP
Is that part of QA aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use
QA GMP amp QC inter-relationship
QC
Part of GMP concerned with sampling
specification amp testing documentation amp release procedures which ensure
that the necessary amp relevant tests are
performed amp the product is released for use only after ascertaining itrsquos
quality
QC amp QAbull Part of GMP which is
concerned with sampling
specifications testing and with in the organization documentation and release procedures which ensure that the necessary amp relevant tests are carried out
bull QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use
QC amp QAbull Operational
laboratory techniques amp activities used to fulfill the requirement of Quality
bull All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QA GMP amp QC inter-relationship
GMP
Is that part of QA aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use
QA GMP amp QC inter-relationship
QC
Part of GMP concerned with sampling
specification amp testing documentation amp release procedures which ensure
that the necessary amp relevant tests are
performed amp the product is released for use only after ascertaining itrsquos
quality
QC amp QAbull Part of GMP which is
concerned with sampling
specifications testing and with in the organization documentation and release procedures which ensure that the necessary amp relevant tests are carried out
bull QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use
QC amp QAbull Operational
laboratory techniques amp activities used to fulfill the requirement of Quality
bull All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QA GMP amp QC inter-relationship
QC
Part of GMP concerned with sampling
specification amp testing documentation amp release procedures which ensure
that the necessary amp relevant tests are
performed amp the product is released for use only after ascertaining itrsquos
quality
QC amp QAbull Part of GMP which is
concerned with sampling
specifications testing and with in the organization documentation and release procedures which ensure that the necessary amp relevant tests are carried out
bull QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use
QC amp QAbull Operational
laboratory techniques amp activities used to fulfill the requirement of Quality
bull All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QC amp QAbull Part of GMP which is
concerned with sampling
specifications testing and with in the organization documentation and release procedures which ensure that the necessary amp relevant tests are carried out
bull QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use
QC amp QAbull Operational
laboratory techniques amp activities used to fulfill the requirement of Quality
bull All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QC amp QAbull Operational
laboratory techniques amp activities used to fulfill the requirement of Quality
bull All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QC amp QA
QC is laboratory based
QA is company
based
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
GMPbull GMP in solid dosage formsbull GMP in semisolid dosage formsbull GMP in Liquid oralsbull GMP in Parenterals Productionbull GMP in Ayurvedic medicinesbull GMP in Biotechnological productsbull GMP in Nutraceuticals amp cosmeceuticals bull GMP in Homeopathic medicines
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
GMPbull Good Manufacturing Practicebull Good Management Practicebull Get More Profitbull Give more Productionbull GMP Training with out tears
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Ten Principles of GMP1 Design amp construct the facilities amp equipments
properly2 Follow written procedures amp Instructions3 Document work4 Validate work5 Monitor facilities amp equipment6 Write step by step operating procedures amp work
on instructions7 Design develop amp demonstrate job competence8 Protect against contamination9 Control components amp product related
processes 10 Conduct planned amp periodic audits
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Beyond GMP
bull Reduce pollution - Zero dischargebull Adaptation of environment friendly methodsbull Consideration for better amp healthier life
tomorrowbull Consideration of ethics in lifebull One should begin with end in mind
otherwise it will be the beginning of the end
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Cost of effective GMPbull In fact Cost benefits ndash positive cost benefits of
GMPQAbull Good plant lay out Smooth work flows Efficient
documentation systems well controlled process good stores lay outs and stores records- These are Good manufacturing practices
bull Reduction in work in process amp inventory holding costs
bull Avoidance of cost of Quality failure ( cost of waste of rework of recall of consumer compensation and of loss of company reputation)
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
List of important documents in GMP
bull Policiesbull SOPbull Specificationsbull MFR (Master Formula Record)bull BMRbull Manualsbull Master plans filesbull Validation protocolsbull Forms amp Formatsbull Records
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
How do GMPs of different countries compare
At a high level GMPs of various nations are very similar most require things like Equipment amp facilities being properly designed maintained amp cleaned SOPs be written amp approved An independent Quality unit (like QC andor
QA) Well trained personnel amp management
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Basic Requirements of GMP
bull All manufacturing processes are clearly defined systematically reviewed amp shown to be capable of consistently manufacturing medicinal products of the required quality amp complying with specifications
bull Critical steps of the process and significant changes to the process are validated
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Why GMP is importantndash A poor quality medicine may contain
toxic substances that have been unintentionally added
ndash A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QUALITY RELATIONSHIPQuality Management
Quality Assurance
GMP
Quality Control
QC
GMP
QA
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
What is Quality Management
The aspect of management function that determines amp implements the ldquoquality policyrdquo
The overall intention amp direction regarding quality as formally expressed amp authorized by top management
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
BASIC PRINCIPLE OFQUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD)
They should also comply with any other applicable regulations pertaining to your specific country
The attainment of this quality objective should be led by the senior management amp requires the participation and commitment by staff by the companyrsquos suppliers and distributors
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
To achieve the reliable quality objective there should be a comprehensive QA system incorporating GMP
The QA system should be fully documented amp its effectiveness should be monitored
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QUALITY ASSURANCE
bull QA covers all matters which individually or collectively influence the quality of a product
All parts of QA system should be adequately resourced with
Competent personnelSuitable amp sufficient premises equipment amp facilities
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Principles of Quality Assurance (QA)
bull Wide-ranging concept Covers all matters that individually or
collectively influence the quality of a product bull Totality of the arrangements
To ensure that the drug is of the right quality for the intended use
bull QA incorporates GMPand also product design amp development which is outside the scope of this module
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration
Ensure that managerial responsibilities are clearly specified
Ensure that production and control operations are clearly specified and GMP is adopted
Organize supply amp use of correct starting amp packaging materials
Ensure that finished products are correctly processed amp checked before release
Ensure that products are released after review by authorized person
Provide satisfactory arrangement to ensure products are stored distributed amp handled appropriately
Put in place a mechanism for regular self inspection internal quality audit
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
GOOD MANUFACURING PRACTICES
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use
Minimize risks bull cross contamination bull mix up
Ensure productsmaterials are traceable to the original source
Product testing is not reliable way to assure product quality Should BUILD quality into the product
Production and quality control functions should be independent of each other
All manufacturing process are clearly defined and systematically reviewed
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
All necessary facilitiesresources for GMP should be provided
adequate qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QUALITY CONTROL
QC is part of GMP
QC is concerned with sampling specification and testing
Manufacturer should have a QC department
QC should be headed by an appropriately qualified and experienced person
QC should be independent from production and other departments
Ensure that the necessary and relevant tests are actually carried out
Ensure that no materials or products will be released for sale or supply until their quality have been evaluated and judged to be satisfactory
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
SCOPE OF QC
Items concerned Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities trained personnel and approved procedures should be available for sampling
inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods
Maintenance of QC records amp failure investigation records
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade composition strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QUALITY CONTROL ACTIVITIES
QC should cover the followinga Samplingb Specificationc Testingd Release procedurese Recalls and complaintsf Decision making in all quality mattersg Definition of product qualityh Laboratory operationsi Release authorisationj Investigation and reporting
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities trained personnel and approved procedures should be available for sampling inspecting and testing and where appropriate environment monitoring
Sampling by QC personnel amp testing by approved methods
Approved test methods Maintenance of QC records amp failure investigation
records Ingredients comply with regulatory specification
(grade composition strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials
and finished products
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
OTHER DUTIES OF QC
Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
PERSONNEL
bull Adequate staff with relevant knowledge experience and capabilities in assigned taska Production and QC are headed by different persons neither of whom shall be responsible to the otherb Responsibilities and authority of key personnel are clearly definedc Training on the understanding of procedures work instruction GMP principles etc
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Personnel Qualifications
bull ldquoEach person engaged in the manufacture processing packing or holding of a drug product shall have education training and experience or any combination thereof to enable that person to perform the assigned functions Training shall be rdquo
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
bull There are competent and appropriately qualified personnel in sufficient numbers to ensure service provision1048698 The responsibilities of all staff should be clearly understood and recorded1048698 All personnel receive initial and continuing
training relevant to their needs1048698 Only staff who have appropriate training are
authorised to carry out that procedure1048698 Training should be structured and continuous
Training records based on SOPs are a good means of evidencing that staff are able to perform tasks1048698 Competency Assessments can also be used
to assess procedural training
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
3 Key PersonnelbullThe head of productionbullThe head of QCbullThe head of QM (QA)
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
The head of production
bull The head of production should be a qualified pharmacist adequately trained possess good practical experience in pharmaceutical manufacture amp managerial skill
bull The head of production should have full authority amp responsibility to manage production of pharmaceutical products
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
The head of QCbull The head of QC should be a qualified
pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QC should given full authority amp responsibility in all QC duties
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
The head of QM (QA)
bull The head of QM (QA) should be a qualified pharmacist have adequate training amp practical experiences which enable himher to perform himher function personally
bull The head of QM (QA) should given full authority amp responsibility in all quality systemassurance duties
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
PREMISESSpecify the requirements of location design
constructions and maintenance of manufacturing premises with respect to the following
a prevention of contamination from surrounding environment and pests
b prevention of mix up of materials and productsc facilities such as toilet changing rooms sampling
areas and QC labd defined areas for certain activitiese wall ceiling drains air intake and exhaust
lighting and ventilation pipe work and light fitting f storage areas
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
bull Suitable location design constructions and maintenance for manufacturing premises ndash defined areas for certain activities (eg
material sampling amp dispensing)ndash wall ceiling drains air intake and
exhaust lighting and ventilation pipe work and light fitting
ndash storage areas of adequate spacendash Physical separation of toilets and QC
lab from production
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Building amp facilities1 Design and construction features 2 Lighting3 Ventilation air filtration air heating and cooling 4 Plumbing 5 Sewage and refuse 6 Washing and toilet facilities 7 Sanitation 8 Maintenance
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Paint Finishhellip
bull Not only building paintwork must be considered but also equipment
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Building Finishes
bull In module 1 we discussed the need for all facility components to complement each other
bull Therefore a good air handling system must be complemented by a building of good design and good finishes
bull On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Building Finishes
Not Acceptable AcceptablePVA Paint Epoxy or Enamel paint Window sills Flush glazed windows Exposed pipes Smooth surfaces Horizontal pipes amp services Concealed services
Open floor drains Hygienic drains
Floor cracks flaking floor surfaces
Homogonous sealed floors ndash epoxy finish or welded vinyl
Ceiling cracks amp joints Smooth sealed ceilings Exposed open light fittings Flush light fittings
Wooden furniture SSteel or Melamine furniture
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Floors drains
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Design and Construction Features
ldquoAny building or buildings used in the manufacture processing packing or holding of a drug product shall be of suitable size construction and location to facilitate cleaning maintenance and proper operationrdquo
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Product Areasbull Premises should preferably
be laid out in such a way asndash To allow the production to take
place in areas connected in a logical order corresponding to the sequence of the operations the requisite cleanliness levels
ndash To avoid crowding and disorderndash To allow effective
communication and supervision
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Weighing Area
bull The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing areas specially designed for that use Such areas may be part of either storage or production areas
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Storage Areas
Specify the requirements concerning storage of materials products with respect to the following
a Space design security and cleanlinessb Storage of quarantine stocksc Storage of hazardous substancesd Conditions of storage area e (eg temperature amp relative humidity)f Receiving of incoming materialsg Stock control (eg FIFO principleh proper labeling on the container)
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Ventilation Air Filtration Air Heating and Cooling
ldquoEquipment for adequate control over air pressure micro-organisms dust humidity and temperature shall be provided when appropriate for the manufacture processing packing or holding of a drug productrdquo
ldquoAir-handling systems for penicillin shall be completely separate from those for other drug products for human userdquo
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Poor amp Good Windows
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
QC Areasbull QC laboratories should be
designed to suit the operations to be carried out in them
bull QC laboratories should be separated from production areas
bull Areas where biological or radioisotope test methods are employed should be separated from each other
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Ancillary Areas
bull Rest and refreshment rooms should be separated from production amp QC laboratory areas
bull Facilities for changing clothes and for washing and toilet purposes should be easily accessible amp appropriate for the number of users
Thank you for Your KindAttention
Thank you for Your KindAttention