validation introduction - gmp consultants, pharmaceutical ......validation eu annex 15 fda:...
TRANSCRIPT
Validation Introduction
Presented by John Montalto
27 March, 2013
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John Montalto
Bachelor of Science
Management Diploma
>15 years of Industry Experience
Consultant to United Nations various Government Regulatory Agencies
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Lei Hao
This activity is a “getting to know you” exercise:
• Introduce yourself
• Validation experience/exposure
5 min/?
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Course structure
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Course objectives
PIC/S Annex 15 Qualification and validation
Process validation
Cleaning validation considerations
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Activity
• With the person next to you, discuss the following:
• Define the term ‘Validation’
• What does ‘Quality’ mean to you?
• What do you expect from a validation program?
• Contribute to the group discussion
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The history of validation
The concept of validation was initially proposed in the mid-1970’s
Several significant issues with high volume aseptic products were realised
The early concept of validation was to verify the robustness of the manufacturing processes
Two US FDA regulators Ted Byers and Bud Loftus are recognised as having significant influence in validation
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The history of validation
Where the early concept of validation was to verify the robustness of the manufacturing processes, later efforts spread to:
Production environments
Media fill processes
Purified water production
Equipment sanitation
Facility services
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The history of validation
Validation activities were (and still are) based on engineering practices.
› For example, how large, complex items of equipment are manufactured, tested, delivered and accepted to fulfil contractual obligations.
› More recently in 2005 the concept of validation spread to cold chain distribution processes.
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The history of validation
Validation continues to evolve, but the core attributes remain consistent:
Improve patient safety
Verify the adequacy of processes
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Influences on validation
|1987 | 2000 |2002 | 2004 | 2006 | 2008 2010 | 2011 |
FDA Guide to Process Validation
EU Annex
15
FDA: Pharmaceutical cGMPs For The
21st Century
ICH Q9
FDA: Quality System
Approach to Pharmaceutical
cGMP
PICS VMP
ISPE C&Q Baseline 5
Guide
ISPE 21st Century
Qualification White Paper
ICH Q8
ASTM E2500-
07
FDA Process
Val. Guidance
Draft EMA
Process Val
ASTM E2500-
07
ICH Q10
ICH Q11
EU / PIC/S Annex
15
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Top 10 Most Frequently Cited GMP Deficiencies (PIC/S Member Authorities) (July 2010 – June 2011)
1. Documentation on manufacturing
2. Design & maintenance of premises
3. Documentation – quality systems elements/procedures
4. Personnel issues – training
5. Design & maintenance of equipment
6. Cleaning validation
7. Process validation
8. Product Quality Review
9. Supplier & contractor audit
10. Calibration of measuring & testing equipment
Source: Presentation by H. Smallenbroek (IGZ, Netherlands) & B. Meow Hoe (HSA, Singapore) on “Review of similarities &
differences of top 10 deficiencies cited by PIC/S participating authorities”, PIC/S Seminar, Cape Town, Nov’11.
Will be repeated (& further discussed) at PDA-PICS Workshop, Geneva 9-10 May 2012.
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Top 10 Most Severe GMP Deficiencies (PIC/S Member Authorities) (July 2010 – June 2011)
1. Design & maintenance of premises
2. Contamination, potential for (chemical, physical, microbial)
3. Design & maintenance of equipment
4. Sterility assurance
5. Batch release procedures
6. Process validation
7. Cleaning validation
8. Investigation of anomalies
9. Documentation – quality systems elements/procedures
10. Regulatory issues – noncompliance with marketing authorisation
Source: Presentation by H. Smallenbroek (IGZ, Netherlands) & B. Meow Hoe (HSA, Singapore) on “Review of similarities &
differences of top 10 deficiencies cited by PIC/S participating authorities”, PIC/S Seminar, Cape Town, Nov’11.
Will be repeated (& further discussed) at PDA-PICS Workshop, Geneva 9-10 May 2012.
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Top Ten GMP Deficiencies found by MHRA (UK) (from MHRA web site Aug 2011)
1. Investigation of Anomalies
2. Quality management
3. Quality management (Change Control)
4. Validation Master Plan & Documentation
5. Corrective Action/Preventative Action (CAPA)
6. Complaints and Product Recall
7. Documentation
8. Equipment Validation
9. Quality Management –Product Quality Review
10. Investigation of Anomalies - OOS
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Why validate?
Validation is:
• A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation.
• Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification
"Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.“
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Laying the foundations
Understanding the principles of validation is the foundation for
ensuring the process produces a quality product consistently.
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Thank you for your time. Questions?
John Montalto
Training Manager / Lead Consultant
www.pharmout.net