good manufacturing practices (gmp)- purpose and principles
TRANSCRIPT
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Good Manufacturing Practices
Purpose and Principles of GMP
DIPSAR
MD. IMRAN MALIK(D.pharm, B.pharm- DIPSAR)
Persuing M.Pharm (Pharm. Management)New Delhi, 14 Aug, 2015
2
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GOOD MANUFACTURING PRACTICES
QUALITY OF DRUGS IS ESSENTIALLY THE RESPONSIBILITY OF MANUFACTURERS.
GMP GUIDELINES ARE A MEANS TO ASSURE THIS VERY QUALITY OF DRUGS.
GMP REGULATIONS WERE INTRODUCED IN THE FORM OF AMENDED SCHEDULE ‘M’ IN 1988.
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PRINCIPLES OF GMP 1. General Requirements Location and surrounding Buildings and premises Water system Disposal of waste
2. Quality assurance (QA)
3. Sanitation and hygiene
4. Qualification and validation
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5. Warehousing area
6. Production area
7. Ancillary areas
8. Quality control area
9. Personnel
10. Quality control area
11. Manufacturing operations and control
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12. Raw materials
13. Documentation and records
14. Self inspection and quality audit
15. Specifications
16. Master formula records
17. Standard Operating Procedures (SOP)
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GMP is actually Good Common Sense
Quality Management
Quality Assurance
GMP
Production and Quality Control
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Quality Management:
What is Quality Management?
The aspect of management function that determines and implements the “quality policy”
The overall intention and direction regarding quality, as formally expressed and authorized by top management
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Intermezzo: the five P's
Premises
Primary materials
People
Procedures
Processes defined and recorded
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Quality Assurance
QUALITY ASSURANCE IS COMPANY BASED.
Quality assurance is a management tool
In contractual situations, it also serves to generate confidence in a supplier
QA, GMP and Quality Control are interrelated aspects of Quality Management
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The position of QA
Director
QA
Production QC lab Other Depts
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Quality Assurance includes:
Responsibility of the Manufacturer for the quality of the product Fit for intended use Comply with marketing authorization Safety, efficacy and quality
Commitment of senior management and involvement of all staff Comprehensively designed and well implemented quality system Full documentation and monitoring of effectiveness Competent personnel, sufficient premises, equipment and facilities
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AIM OF Good Manufacturing Practices
That part of QA that ensures that products are consistently produced and controlled Quality standards Marketing authorization
Aim: Diminishing risks that cannot be controlled by testing of product Contamination and cross-contamination Mix-ups (confusion)
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Basic requirements for GMP: Clearly defined and systematically reviewed processes
Qualification and validation is performed
Appropriate resources are provided: Qualified and trained personnel Premises, space, equipment and services Materials, containers, labels Procedures, storage, transport Laboratories and in-process control
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Clear, written instructions and procedures
Trained operators
Records of actions, deviations and investigations
Records for manufacture and distribution
Proper storage and distribution
Systems for complaints and recalls
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GMP = continuous urge for improvement
Involvement of the management
Annual Product Quality Review
Complaints handling
Self-inspection
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Annual Product Quality Review
Objectives to do an Annual Product Quality Review:
To review and verify the consistency and appropriateness of the existing process
To identify and highlight any trends in the process, e.g. in analytical results, yields etc.
To identify any possible product or process improvements
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Complaints handling “All complaints and other information concerning
potentially defective products must be carefully reviewed according to written procedures and corrective action should be taken.”
Investigation and evaluation should result in appropriate follow-up actions
All decisions and measures taken should be recorded Referenced in batch records Records reviewed - trends and recurring problems
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Self-InspectionPurpose is to evaluate whether a company’s operations
remain compliant with GMP The programme should
cover all aspects of production and quality control be designed to detect shortcomings in the implementation of GMP recommend corrective actions set a timetable for corrective action to be completed
Be performed routinely Also on special occasions such as
Recalls Repeated rejections When a GMP inspection is announced by the national drug
regulatory authority
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Summary and conclusions:
GMP is mandatory in countries with a regulated pharmaceutical market, and in the WHO Prequalification Programme too.
GMP's are very similar, they are nothing but Good Common Sense Good Practices cover all aspects of company's activities prior to sales GMP is not a reward, nor an external assignment, it should be built into the
company Just like quality, which should be built into the product The role and involvement of senior management is crucial GMP means an urge for continuous improvement, 3 of the tools to do so are:
Annual Product Quality Reviews Complaint handling and trending Self-inspection
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THANK YOU