The document discusses the relationship between PIC/S and ICH and their roles in harmonizing GMP standards globally. PIC/S focuses specifically on GMP inspections and developing harmonized GMP standards and training inspectors. ICH focuses more broadly on safety, efficacy, quality and regulatory guidelines. Together they aim to promote reliance between regulatory authorities and open doors of trust through mutual recognition agreements and understanding of inspection systems. The document provides a comprehensive overview of their goals and collaboration to harmonize standards for patients worldwide.

1. PIC/S & ICH
Obaid Ali & Roohi B. Obaid
Alumni International Forum of Regulators
CDER-USFDA, HPFB, Health Canada & WHO-PQP
121st CCK & 21st CQS Session
22nd Jan 2023, Sunday, Hotel Marriott, Karachi

2. Disease
has no Boundary
Pain is similar, all humans
deserve same quality of drug &
treatment

3. Diversity
across the world
Sovereignty of every country
allows to set its standards to
control quality of drug for safety
of their citizens

4. Disease
has no Boundary
Pain is similar, all humans
deserve same quality of drug &
treatment

5. Disease
has no Boundary
Pain is similar, all humans
deserve same quality of drug &
treatment
Globalization
comes in

6. Diversity
across the world
Sovereignty of every country
allows to set its standards to
control quality of drug for safety
of their citizens

7. Diversity
across the world
Sovereignty of every country
allows to set its standards to
control quality of drug for safety
of their citizens
Harmonization
comes in

8. Phase
I
Phase
II
Phase
III
Phase
IV
Clinical trial permission …. Data compilation ….
…. Dossier of Studies …. Review of application ….

9. Commercial Manufacturing …. Generic Drug ….
…. Commercial Manufacturing ….

10. Phase
I
Phase
II
Phase
III
Phase
IV
Clinical trial permission …. Data compilation ….
…. Dossier of Studies …. Review of application ….

11. Phase
I
Phase
II
Phase
III
Phase
IV
Clinical trial permission …. Data compilation ….
…. Dossier of Studies …. Review of application ….
Will it perform in the same way
to deliver promise?
Will it be able to catch defects
& new knowledge?

12. Commercial Manufacturing …. Generic Drug ….
…. Commercial Manufacturing ….

13. Commercial Manufacturing …. Generic Drug ….
…. Commercial Manufacturing ….
Will it perform in the same way
as innovator’s drug?
Will it be able to catch defects
& any signals?

14. Dossier Reviews Site Suitability

15. Dossier Reviews Site Suitability
Challenges

16. Dossier Reviews Site Suitability
Challenges
Different Approach
Different Regulatory Language
Different Standards

17. Dossier Reviews Site Suitability
Globalization & Harmonization

18. Dossier Reviews Site Suitability
Globalization & Harmonization
Since 1990 … Since 1970 …

19. Dossier Reviews Site Suitability
Globalization & Harmonization
Since 1990 … Since 1970 …
Regulatory
Obligations

20. Common
Regulatory language, Scientific
standards, Regulatory approach
…
Promotes
Harmonization, Quality,
Reliance, Technology,
Smartness …

21. Common
Regulatory language, Scientific
standards, Regulatory approach
…
Promotes
Harmonization, Quality,
Reliance, Technology,
Smartness …
Open for Industry too
through Associations

22. Common
Regulatory language, Scientific
standards, Regulatory approach
…
Promotes
Harmonization, Quality,
Reliance, Technology,
Smartness …

23. Common
Regulatory language, Scientific
standards, Regulatory approach
…
Promotes
Harmonization, Quality,
Reliance, Technology,
Smartness …
Limited to
Government Bodies

24. Common
Regulatory language, Scientific
standards, Regulatory approach
…
Promotes
Harmonization, Quality,
Reliance, Technology,
Smartness …

25. ICH
Safety, Efficacy, Quality & Regulatory

26. ICH
But does not speak about GMP

27. PIC/S
GMP Inspections is the subject

28. PIC/S
Standards, tools, approach, capacity,
capability & honesty

29. PIC/S
What is different in GMP?

30. PIC/S
PIC/S itself does not approve
any facility ….
Anything which is approved by member
for its own may not considered approval by
the club, if it is so, it will be notified
PIC/S is not a regulatory body but a club
of inspectorate authority of regulatory
bodies

31. PIC/S
PIC/S does not offer any
compliance certificate or
membership to any company
PIC/S gives membership to the respective
inspectorate division of regulatory
authority and has no direct relation with
even manufacturing associations

32. PIC/S
Neither FDA nor EMA
recognize WHO inspections
This is important to
understand, why it is so?

33. PIC/S
Neither FDA nor EMA
recognize PIC/S member
(Malaysia) inspections
This is important to
understand, why it is so?

34. PIC/S
Approved Facility
With sincerity,
It is a wrong word. Giving
perception of ignorance
One may write
The facility is compliant with PIC/S
standards. This compliant is verified by ------
------------ Competent regulatory authority
(member of the PIC/S)

35. PIC/S
Opens the Door of Trust
• Mutual Recognition Agreement
• Memorandum of Understanding
• Mutual Reliance
• Independent Reliance

36. PIC/S
Opens the Door of Trust
• Mutual Recognition Agreement
• Memorandum of Understanding
• Mutual Reliance
• Independent Reliance
Inspection does not mean market authorization
Product development is the key

37. PIC/S & ICH
A Comprehensive, System Oriented Understanding

38. PIC/S
Opens the Door of Trust
Non-binding informal
cooperative arrangement among
regulatory authorities in the
field of GMP of medicinal
products
54 participating authorities till
date

39. PIC/S
Opens the Door of Trust
Developing & promoting
harmonized GMP standards
Training of inspectors of
regulatory authorities
Facilitate networking &
cooperation

40. PIC/S
Opens the Door of Trust
Developing & promoting
harmonized GMP standards
Training of inspectors of
regulatory authorities
Facilitate networking &
cooperation
Council
… leading world …
Assessing & re-assessing
inspectorate performance

41. PIC/S
Opens the Door of Trust
Accession
• Legislative requirement
• Inspector capacity
• Licensing system
• Inspection system

42. PIC/S
Opens the Door of Trust
Accession
• Legislative requirement
• Inspector capacity
• Licensing system
• Inspection system
Detailed
Assessment before
granting
membership

43. PIC/S
Opens the Door of Trust
We Know the Unknowns
• Competency & Capability
• Independence & Impartiality
• Quality Management System
• Complaints Management
• Etc.

48. 20 Annexures
What to do? How to do?

49. PIC/S
Track the Journey
GMP Annex 1

50. ICH
Agreed Guidance
Q Q1 to Q14
S S1 to Q12
E E1 to Q21
M M1 to M15

51. ICH
Quality Guidance Q8 Q9 Q10

52. ICH
Quality Guidance Q8 Q9 Q10

53. ICH
Quality Guidance
Q11
Development & Manufacture of
Drug Substance
Q12 Lifecycle Management
Q13
Continuous Manufacturing of Drug
Substance & Drug Product
Q11 Analytical Procedure Development

54. 37
New Drugs
in 2022
2021
51 Drugs on an average from 2017
Alzheimer - Controversy

55. Pharmaceuticals
13117
Biologicals
5500
Animal Drugs
2961
Medical Devices
25901
+ 47000
We know where we are
FDA

56. Pharmaceuticals
13117
Biologicals
5500
Animal Drugs
2961
Medical Devices
25901
+ 47000
We know where we are
FDA
20,000
Rx
621
Rx
1600 6700

57. Thanks