challenges in global quality management pptx
DESCRIPTION
Global Quality Management is dependent on the Regulations. Harmonization of Pharmacopeial monographs is a challenge. One needs to identify the critical Variables and have on line controls to manage them. Training of the staff is the key. Data integrity is another challenge that Indian Pharmaceutical manufacturers have to overcome with sincere attempt and change in the mind set. Process development is another challenge. ICH Guideline and US FDA SOP list is one of the ways to meet the challenges.TRANSCRIPT
Nandkumar Chodankar (Ph D Tech)CEO
ASolution Pharmaceuticals Pvt. Ltd.11-A Mittal Chambers, Nariman Point
Mumbai, India, 400021
Challenges in Global Quality Management
Nandkumar Chodankar (Ph D Tech) 2
We shall Discuss
1. WHAT is Global Quality? WHAT are the Challenges?
2. WHY Management of Quality is Required?
3. WHO Manages Quality?
4. HOW Can One Manage Challenges in Global Quality?
5. WHAT Are The Variables? Can we Identify them?
6. Process Development - Most important Challenge
7. List of SOPs from The US FDA to Meet Challenges
8. Summary8/18/14
What is Global Quality? Is it One Quality Standard for
All?Is this a Challenge by itself?
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One Quality All The Time
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http://www.associerge.com/the-globe-of-the-earth/satellite-image-the-world-283642/
Satellite Image The World
Global QualityOne Quality Across the Globe
WHY Management of Quality is Required?
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Consequences of Quality Failure
Lack of Therapeutic Effect leading to prolonged illness or even death
Toxic and adverse reactions
Waste of limited financial resources
Loss of credibility of health care delivery system
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Concern about the quality, authenticity, performance, or safety of any
medication (and Medical device)
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Product Quality Management Challenges during manufacturing, shipping, or storage (SOPs):
Suspect Counterfeit Product (Bar coding)
Contamination (cGMP)
Defective components (Inspection)
Poor packaging or Product mix-up (Inspection)
Questionable stability (Stability Plan)
Labeling concerns (Better Supervision).
Consequences of Quality Failure
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WHO Manages Quality?
Regulators (Customs, Politicians, Bureaucrats)
QU (Q A / QC/ RA?)
Manufacturer, Production
Supply Chain (Distributors, Transporters, Sourcing department)
Advertising Agencies & Media
Doctors and Nurses, other Staff
Pharmacist
Patient? (Self Medication)
Relatives and Friends
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SOPs
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Are Challenges for &/or from Regulatory Authorities the Same?
India & Neighboring Countries
ROW
EU
US
Japan
Undeveloped Countries
Global Expectation: Harmonization is difficult
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HOW Can One Manage Challenges in Global Quality?
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Tools made Available by Regulatory Authorities
ICH & Other Regulatory Guidelines
Quality Risk Management
Quality by Design
Process Analytical Technology
Development & Clinical Study Regulations
Review of the data Submitted
Inspections for Assurance
Pilot studies by Authorities
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Challenge -
Knowing vs.
Implementatio
n
Challenge -
Harmoniza
tion
WHAT needs to be Managed? WHAT are the Variables?
Quality by Design, Quality Target Product Profile, Critical Steps & Parameters,
Critical Variables, Quality Risk Management, Process Technology,
Continuous Validation, Patient’s Welfare
Identification Challenge
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Purpose of QUTo help ensure that each medicine reaching a patient is safe, effective, & is of acceptable quality
For Primary Health Care, the most important characteristics of a pharmaceutical product are
Identity,
Purity,
Strength,
Potency,
Uniformity of dosage form,
Bioavailability, and
Stability
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Conducting Clinical studies & Quality of material used for this study is most important
Product Design (QTPP) Challenge
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Comprehensive Quality Assurance Program- A Challenge
Developing Systems to have proven, safe and efficacious drug, presented in an appropriate dosage form to have longest possible shelf life
Selection of Suppliers with acceptable quality
Pharmaceuticals received from commercial suppliers and donors should meet specified quality standards at the time of delivery (Assuring & Ensuring)
Approved Packaging & Labeling
Repackaging activities and dispensing practices
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No Compromise on Storage and transportation conditions
Reporting, Documenting & Addressing Product quality concerns (prescribers, dispensers, users)
Procedures to Implement Product recall of defective products.
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Challenge: Knowing Vs Application Driving GMP from Top to Bottom
Comprehensive Quality Assurance Program- A Challenge
WHAT Are The Variables?Can we Identify them?
The Variables May be Common for APIs and
Finished Dosages
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Challenges To Manage: WHAT Affects Quality?
People Involved in all activities
Equipment
Analytical Methods / Measurements
Manufacturing Technology
Quality of Materials
Environment
Packaging
Transportation & Storage conditions
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1. PeoplePeople
Method of Selection, Who, Where, What
Education, Experience, Past records & Job changes, Attitude & Aptitude, Interest, etc.
Training:
Quality Training program
Material for training
Training of staff and Trainers
Refresher course
Evaluation of training effectiveness
Performance appraisal
Training & Supervision of staff members
SOPs 8/18/14
People
Managem
ent
Challenge
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2. Equipment (Qualification)
Suitability of Equipment
Qualification & Calibration
Wear & Tear of Equipment
Location & Protection of Equipment
Preventive Maintenance of Equipment
Accessories and contact parts,
Lubricants, gaskets, seals
Efficiency of Equipment
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Quality Vs Customer
Commitment
Preventive Maintenance
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3. MeasurementSuitability of the measuring instrument
Qualification & calibration
Usage and life span
Location & protection
Preventive maintenance of Instruments
Accessories and machine parts,
Supporting spares, seals (lamp, columns)
Software / computer validation
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4. Process & Technology (SOPs)
Manufacturing Process: Robustness
Validated Manufacturing formula, its Technical Process Knowledge
Controls for Contamination & Cross Contamination
In-process monitoring
Specification at each stage and of the end product
Validated Analytical method for testing & Stability
Documentation to investigate
Deviation & Change Control
OOS, OOT
Continuous improvement
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5. Materials
Quality of Materials
Approved Specification & Test Methods
Approved Manufacturer & Supplier
Labeling & Packing as per
Storage conditions
Stability
Suitable Transportation & Control
Contamination in the material
Impurity Profile
Storage after dispensing a part quantity
Lot to lot variation
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6. Manufacturing Environment
Surrounding Areas
AHUs, HVACs,
Temperature
Humidity
Contamination & Cross Contamination
Dust / Particulate matter
Man, Material, Equipment, Trash movement control
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Combined Effect of Variability
1. People
2. Equipment
3. Measurement
4. Process & Technology
5. Materials
6. Environment (Facility) Identifying the criticality of each and
devising a control strategy for minimizing variability due to combined effect of these factors, during manufacturing, is the key for QRM.
Machine
Machine
Measure System
Prior Ops
Materials
Materials
Quality Risk Management
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Process Development
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Robustness, RuggednessConsistency, Critical Parameters,
Controls &Efficiency
Generating Process
Knowledge
26 8/18/14Nandkumar Chodankar (Ph D Tech)
EASY MAX
Process Investigation
& Process Research
OPTIMAX
Process Optimization
FBRM
Focused Beam Reflectance MeasurementOn Line Crystal size / Polymorph Monitoring
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Challenge to Development of critical Strategy for Process Modeling
Manipulated Inputs
Disturbance Inputs
Measured Outputs
Unmeasured Outputs
b) Control Representation
Manipulated Inputs Measured Outputs
Unmeasured OutputsDisturbance Inputs
Controller
a) Input/Output Representation
Process
Process
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API Manufacturing Steps
RM- Dispensing
Packaging
NIR -Identification
Air- Moisture – NIRParticle size- FBRMNIR, HPLC
NIRRaman Spectra
Critical SynthesisFTIR, HPLC, Raman Spectra
Carbon Treatment Crystallization
Filtration
Filter
HPLC, NIR
Milling / Blending Drying FBD
Load cell
GC MS Vapor lineRaman Spectra
NIR, HPLC Particle Measurement
Raman Spectra
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1. Responsibilities and Procedures of QC
2. Sanitation Procedures
3. Use of suitable rodenticides, insecticides, fungicides, sanitizing agents
4. Cleaning & maintenance of equipment
5. Performance of automatic, mechanical and electronic equipment
6. Receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers & closures
7. Standards or specifications, method of testing, and method of cleaning, sterilization, and processing to remove pyrogenic properties of drug substance for drug product containers and closures
8. Production and process control 8/18/14
List of SOPs from The US FDA To Meet Challenges
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List of SOPs from The US FDA To Meet Challenges
9. Sampling & Testing of in-process materials and drug products
10. Prevention of objectionable microorganism in drug products which are required to be sterile
11. Prevention of microbiological contamination of drug products purporting to be sterile, including validation of any sterilization process
12. System for reprocessing batches do not conform to standards or specifications, to insure that reprocessed batches conform with all established standards, specifications, and characteristics
13. Receipt, identification, storage, handling, sampling, examination & /or testing of labeling and packaging materials.
14. Control procedures for the issuance of labels. 8/18/14
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15. Packaging and labeling operations, prevention of mix-up and cross contamination, identification and handling of filled drug products containers that are set aside and held in unlabeled conditions and identification of drug product with a lot or control number that permits determination of the history of the manufacturing and control of the batch
16. Warehousing
17. Distribution of drug products
18. Laboratory controls
19. Testing and release of materials
20. Stability testing
21. Special testing requirements
22. Notification of responsible officials of investigations, recalls,
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List of SOPs from The US FDA To Meet Challenges
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23. Written and oral complaints procedures, including quality involving specifications and failures, and serious and unexpected adverse drug experiences
24. Holding, testing, and reprocessing of returned drug products
25. Drug product salvaging
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List of SOPs from The US FDA To Meet Challenges
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SummaryThe Challenges in Global Quality Management “Quality Strategy”: Product that meets Identity, Purity, Strength, Potency, Uniformity, Bioavailability, Stability and Affordability.
Harmonization of standards, product specifications and regulations is one of the major challenges for Indian Manufacturer and Exporter.
Quality failure may lead to Lack of Therapeutic Effect leading to Toxic and adverse reactions, prolonged illness or even death. This results into the loss of limited financial resources of the patient and the Loss of credibility of the health care delivery system.
8/18/14
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SummarySuspect Counterfeit Product, Contamination, Defective Components, Poor Packaging or Product Mix-up, Questionable Stability, and Labeling Concerns.
“Product Quality Management during Manufacturing, Shipping, & Storage” (cGMP & appropriate SOPs).
Assuring appropriate Product Design QbD, Identifying QTPP, and CQPAs, Continuous Process Validation, PAT and QRM using these throughout Product Lifecycle.
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Write & Follow SOPs
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THANK YOU for your Patience
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