23 April & 21 May 2017 Discussion Forum

1. Discussion Forum on ICH Q7 & Q11
Development & Qualification of Suppliers
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
23 April 2017 (Program A)
21 May 2017 (Program B)

2. Development & Qualification
of Suppliers

3. Opening Message
Science, Trust and their Verification
Frame Strategy & Progressive Initiatives
Closing Message

4. Ingredients Process Product
Opening Message

5. Ireland-
Paroxetine,
Oct 2013
Contaminated
with waste
tank
Did not give
attention, kept
continuance of
distribution
Recall … RA
Look Analyze Predict

6. Science, Trust & their Verification
Independent
Pre-Audit
Assessment
Site Inspection
Post Audit
Assessment

7. Flow diagram(s) of
manufacturing
processes
Manufacturer(s)
Quality management
Personnel
Building and facilities
site/ building map
Process equipment
Documentation
& records
Materials
management
Production and in-
process controls
Insight
Cont’d

8. Packaging and identification
labeling of ingredients and
intermediates
Storage &
distribution
Laboratory controls Validation
Change Control
Rejection and
re-use of
materials
Complaints
and recalls
Contract
manufacturers
& laboratories
Agents, brokers,
traders, distributors,
repackers, & relabelers
Insight

9. Frame, Strategy and Progressive Initiatives

12. Let’s challenge and speak
Audits are not required
Sample testing is sufficient
Only questionnaire is sufficient
Virtual audit is sufficient
NO YES

14. Paper Tiger otherwise
invites and promotes
• Negligence/slopiness
• Cutting corners
• Deliberate non-compliance
• Cheating
• Counterfeiting
• Crime

15. Limited
Resources
Cost
effective
Over
emphasis
Patient
safety
Guidelines
Competitive
environment
Relationships
Better
quality
Harmonization
Compliance
Regulations
Responsibilities

16. Patient Safety

17. Why Audit is necessary?
Detects GMP non-
compliance
Detects Fraud and
Counterfeiting
A system based on
trusting on audits
only does not
work!

18. Why Audit is necessary?
Because patient safety is of paramount importance
Detects GMP non-
compliance
Detects Fraud and
Counterfeiting
A system based on
trusting on audits
only does not
work!

19. Global Radar
navigates
Mandatory API GMP Certification
Global prioritization of API inspections
Focus on fraud & counterfeiting
Sanctions & penalties
Legal liability of Qualified Persons

20. Progress but do not pursue profit at the
expense of consumer safety. It will not
favor every time
Closing Message

21. Your product is your child. Please take care because
some time damages of uncertainty are irreversible
Closing Message

22. Please make zero
tolerance as a habit ...
“But no one came.
Because no one ever
does” (Thomas Hardy .. Jude the
Obscure)
Closing Message