ICH Q7 & Q11

Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries

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

2. Not the view of
DRAP
Current
judgment
No obligation
on DRAP
Regulatory
experience
ReferencesUS-FDA WHO ICH NRAs
DISCLAIMER

3. ICH-Q7 & ICH-Q11
Introduction

4. “Platform Manufacturing”
How many people are aware with this terminology?

5. Can all give
same quality of
product?
There are different types of rice

6. Let’s imagine a
scenario and think …

7. Water coming from supplier
Stored in a tank before entering
in API Mfg industry
Tank has a small hole
Will it have
impact on
API Quality?

8. Good
Manufacturing
Practices
API
Q7
Development &
Manufacturing
DS
Q11

9. API/DS
Final Product

10. Q7
SM
IM
API

11. Q11
Chemical BiotechnologicalBiological

12. Staring
Material
Intermediate
API
Simple
Complex

13. What is a Starting Material?
Contributes an important structural part of the API
Compound well defined in chemical literature(name, chemical
structure, chemical/physical properties, and impurity profile)
Synthesized by commonly known process
Q7

14. Re-definingStarting Material
Marks the Start of the Manufacturing Process
Manufacturing steps before are not described
Manufacturing steps before need not be performed with GMP
Changes in manufacturing steps before need not be reported to Agency
Each Branch of a Synthesis will begin with One or More Starting
Materials
Q7

15. What is an API?
Asubstanceorcompoundthatisintendedtobeusedinthe
manufactureofapharmaceuticalproductasatherapeutically
activecompound(ingredient)
Q7

16. API-DS, Characteristics
Elucidation of structure
Impurities
Specifications & its justification
Analytical procedure
Analytical method validation
Q7

17. API-DS, Characteristics
Potentially genotoxicimpurities in DS
Atorvastatinexistsincrystallineand
amorphousforms.Theamorphousforms
areverysensitivetooxidationgiving
variousepoxidedegradationproductsthat
isconsideredastructuralalert.
Q7

18. API-DS, Characteristics
Potentially genotoxicimpurities in DS
Oxcarbazepin:Acridinederivativesare
potentialdegradationproductof
oxcarabazepinthathavesomeDNA
bindingcapabilities
Q7

19. Development
Manufacture
Steps designed to reduce impurity
1
2
3
Q11

20. Traditional
Approach
Enhanced
Approach

21. Set points & Operating Ranges
Trust on process reproducibility
Release on meeting established criteria
T
R
A
D
I
T
I
O
N
A
L

22. Science & Risk knowledge
Identify & understand process, CQA
Develop a Control Strategy & lifecycle
E
N
H
A
N
C
E
D

23. Traditional & Enhanced Approaches
are not mutually exclusive
One can use any of them or
both of them together

24. Take Home Message
Level of scientific knowledge will
determine the confidence and predict the
regulatory flexibility