Develop to navigate tomorrow

1. Centre for Quality Sciences
Pharmaceutical Quality
Science & Compliance the only way
PPE Conference, 25 Aug 2020
Obaid Ali
R. Ph., M. Phil., Ph. D.

3. No new molecules,
Dependent on import for Knowledge,
Technology, Equipment,
Materials, Excipients, Etc. etc.
Poorly sensitized to real time
observations & real world evidences
73 years of Independence

4. Perfect Success & Perfect Failure
Uncertainty, Shortages,
Quality Concerns, Import Alerts,
Export Restrictions, Knowledge Crisis,
Cross-pollination of Myths,

5. Based on
Quality of Development
Post-marketing Changes
Marketing Authorization

6. Randomized Controlled Studies
Phase III Clinical Studies
Placebo/Nocebo Effects of real world

7. Same Therapeutic Outcome
Assurances in Real World
depend upon
Quality of Development &
Effectiveness of QMS
Challenges .. Challenges .. Challenges

8. Challenges
Abuse, Lack of Adherence,
Availability, Affordability
Quality & Authenticity of
products

9. Challenges
Difficulty in listening
voices of patients
Uncertainties in the
current states

10. Evidence is the Key
Pharmaceuticals are better than
placebo in laboratory & clinical
trials

11. Real World
Development of
Humans, Policies, Procedures
has to be by design

12. Professional Development
Why, How & What?
Increase awareness
How to facilitate self
development
Self authorship

13. Cause & Effect relationships
are self evident
Best practices work
Cause & Effect relationships are
multifactorial,
need expertise to understand
Good practices work
Cause & Effect relationships
are not known
Research & development
are required
Cause & Effect relationships
are not known
Extreme sensitivity to
initial conditions
Cause &
Effect
Relationship

14. Self assure before giving
assurance to others
How to develop
Professionals, Policies,
Process, Product

15. 21st Century
Patient centric
Personalized medicine
Real world evidences

16. Learn
Conscious thinking
with sub-conscious mind
Acquired immunity to change
Feeling system, Knowing
System,

17. Education, Training & Experience
Practical contact with things in
the real world
How do you know
what you know

18. Experience Economy
Education & training are
necessary but not sufficient
Experiential learning is key

19. Big Data
Our experience is more important
than the material

20. Towards Systemic Transformation
We need to free ourselves from
average thinking

21. Development
Errors of Omission have to be
eliminated by Quality by Design
Error of Commission have to be
eliminated in Operation by self
authorship of SOPs

22. Breaches in Assurance of
Data Integrity
A symptom of retarded
professional development
A symptom of broken system

23. BAD-I
Why do people cheat?
Why do we manipulate data?
We want to look good & looking
good is low order of
consciousness

24. 2007 - 2012
7193

25. 2013 - 2019
Class I - 1139
Class II - 8034
Class III - 1070
Unclassified - 40
10284

26. NDAs 526
ANDAs1186
Pharmacy 1580

27. cGMP Issues 905

28. cGMP Issues 905
Microbial Contamination 741

29. cGMP Issues 905
Microbial Contamination 741
Stability 606

30. Degradation 339

31. Degradation 339
Particulates 302

32. Degradation 339
Particulates 302
Data Integrity 266

33. Dissolution 198

34. Dissolution 198
Super potent 116

35. Dissolution 198
Super potent 116
Potency Failure 106

36. Tablet Injection Solution
1697 10611501

37. Capsule Creams Suspension
746 115214

38. Ointment Syrup
51 45

39. Don’t Use & Don’t Tell
Tell us, we will do it
Don’t aim at minimum, it will
be missed

40. CAPA are not
Continual Improvement
You can only improve a process
when you are in a state of control
You can’t improve when it is in
need of Corrective & Preventive
Actions

41. Effective leaders develop others
From
Looking good
to
Seeing good

42. Centre for Quality Sciences
Thanks
PPE Conference, 25 Aug 2020
Obaid Ali
R. Ph., M. Phil., Ph. D.