Seminar on "Advanced Pharmaceutical Technology & Practice to Compliance with Challenging Standards" organized by Austar, China & Morgan, Pakistan attended by over hundred participants from different pharmaceutical industries of Karachi & Lahore

1. The Evolving Quality Expectations
& Reshaping Strategy of Controls
in Pharmaceutical Manufacturing
Hotel Pearl Continental, Karachi
26 April 2018
Obaid Ali & Roohi B. Obaid

2. This presentation discusses Regulatory Science,
nothing more & nothing less
Reference: US-FDA Documents / Scientific Articles
Personal point of view & nothing to disclose
Disclaimer

3. Back & side mirror reality
Dashboard Story
Windscreen Reality

4. A lot of Experts
Seminars
WHO /
USP
Political
Claims
Headlines
Molecules
Conferences

5. We know
Positioning
of Pakistan’s Regulatory Authority
Pakistan’s pharmaceutical products

6. Some Relative Facts
>135 manufacturing facilities approved for GMP by US-FDA
Approx. 8 billion USD export/imagine contribution in
healthcare system
Manufacturing from new to generic drug

7. Some Relative Facts
US-FDA has multiple offices
Expending billions of USD
More than 100 inspectors for inspections

8. Some Relative Facts

9. Global Radar & Navigation
Missing
toxicological
studies to qualify
an unqualified
impurity
Unacceptable
physical
properties for
drug product
Need full-term
stability data to
establish
expiration dating

10. Global Radar & Navigation
Failure to identify
or include CQAs
or methods for
controlling them
Insufficient data to
support use-related risk
analysis & any human
factors studies assoc.
with proposed product
Insufficient data
to support
drug/device
compatibility

11. Global Radar & Navigation
Lack of safety assessment of extractables and leachables,
inadequate assessment of extractables and leachables, or
submission of that assessment in an unsolicited amendment

12. Global Radar & Navigation
Data Integrity Culture of Quality

13. Trustworthiness / Integrity of Data
Data that is reliable
Data that is authentic
Data that is useable
Complete & Accurate
Proven to be what it say, it is
Can be located, retrieved, presented & interpreted

14. Culture of Quality Quality Metrics
Lagging Metrics & Leading Metrics

15. Lagging Metrics
Batch Failure
Right First Time
OOS Investigation
Leading Metrics
Quality System
Effectiveness
Process Capability
Quality Culture Index

16. Indiscriminative Citations that still revolve around
Failing to process/investigate
Consumer Complaints
Failure to do
Annual Product Review
Failing to extend their investigation of problem into other lots of
products that might or were affected

17. Indiscriminative Citations that still revolve around
Did not identify, report or investigate the OOS results

18. Indiscriminative Citations that still revolve around
The lack of reliability and
integrity of data is a serious
GMP observation that raise
concern with all data
generated by the company

19. Improving Speed & Quality in Drug Manufacturing
Continuous Manufacturing
as a New Approach has
potential to gain popularity
in time to come

20. Continuous Manufacturing
Eliminate manual
handling & human error

21. Continuous Manufacturing
Online monitoring &
controls enhance quality

22. Continuous Manufacturing
Increased efficiency &
reduced manufacturing
time

23. Continuous Manufacturing
Smaller equipment & less
manufacturing space
reduce cost of ….

24. Continuous Manufacturing
Respond more promptly in
case of drug shortage

25. Lets keep eye open to make wheel alignment
compatible with road and its turning

26. Independent / Separate
Risk ....
Assessment Control
New

27. Fast public release of
New
Non Compliance
Statement

28. No more conditioned GMP with
New
Non Compliance
Statement

29. Specific guidance to release
New
Batches of critical
drug products

30. Lets move beyond regulatory compliance & explain opportunity to capture
unexpected event before it happens
Respect & use knowledge, experience, data, pattern, trend & good science to
improve efficiency & maintaining culture of quality

31. 1/5
Tie with Quality is
a Core Value
Simple, loud & clear

32. 2/5
Setting ethical
standards & Training

33. 3/5
Openness &
transparent Reporting

34. 4/5
Recognition of
Consequences

35. 5/5
Hear the gut &
ground sound

36. Remember
Please
Meet all requirements of regulatory
sciences
Prove product understanding (CQAs)
Mitigate Risks
Provide supporting data

37. Remember
Please
GMP is not complete if you don’t have
post marketing surveillance program

38. Thank
You