Discussion Forum on ICH-Q9 at ICCBS, University of Karachi on 23 July 2017

1. Discussion through
Scenarios and Events
Almas Altaf
Pharm.D., MS, R.Ph.
Discussion Forum on
ICH-Q9

2. Generally speaking an activity that in
future may have some consequences is
called
1

3. 1
Risk Opportunity Issue Hazard
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500
600
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4. Risk combines the chance of something
happening along with the amount of
harm it can do.
2

5. 675 44
TRUE FALSE
No. of Responses
2

6. 3
Scenario 1: Every finished drug product is
required to be tested before release to market. For
the purpose different tests and specifications are
approved by the Regulatory Authority.
Remember compendial monographs are
considered minimum requirement for the same.

7. 3
(a) Do you think any of the attributes of end
product testing may be waived upon using
the approach of Quality Risk Management
without approval of Regulatory Authority.

8. Yes No
Blank / Don’t
Know
Explanatory
answers
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9. 4
Considering Scenario 1 (b) Can result of in-process testing
be used in favor of waiver of attributes of end product
testing through the approach of Quality Risk Management,
(e.g. if content uniformity has been done before packaging,
can waiver of content uniformity be given in end product
testing).

10. Yes No
Blank / Don’t
Know
Explanatory
answers
No. of Responses 241 170 84 224
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11. 5
Scenario 2: In a scenario where a "Combination" of two
already approved and marketed products belonging to
the same therapeutic group (that are known for their
synergistic effect upon co-administration and there is no
evidence of chemical incompatibility) is applied for the
market authorization based on clinical studies of
individual molecules.

12. 5
Does Quality Risk Management approach provides
flexibility to Regulatory Authority that a
combination of both of them is considered for
approval by the Regulatory Authority for marketing
without clinical studies.

13. Yes No
Blank / Don’t
Know
Explanatory
answers
No. of Responses 112 289 95 223
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14. Questions & Answers
Dr. Iftikhar A. Jafri & Dr. Obaid Ali
Post Lunch session (02.15 to 02.45 pm)

15. Aqib Zahoor
12 year experience in
Chemical and Pharmaceutical Sciences
If QRM has been successful in improving product
quality, we would expect to see a decrease in the number
of recalls over time?

16. Aqib Zahoor
12 year experience in
Chemical and Pharmaceutical Sciences
What are the most common quality related risk factors
which causes recalls in Pakistan?
1) Lack of sterility assurance, 2) OOS releases, 3) cGMP
Deviations,

17. Madiha Sohail
03 year experience in
Pharmaceutical & Nutraceutical
What are potential sources of information for knowledge
management?

18. Madiha Sohail
03 year experience in
Pharmaceutical & Nutraceutical
Will regulatory agencies expect to see a formal knowledge
management approach during inspections?

19. Madiha Sohail
03 year experience in
Pharmaceutical & Nutraceutical
How does a company demonstrate implementation of
PQS in accordance with ICH Q9?

20. Muhammad Rashid
8 year experience in
Quality Assurance & Compliance
Can we eliminate the risk through implementing Quality
Risk Management?

21. Now be prepared for the questions

24. End Product Testing can be replaced with
Real Time Release
Yes No
1

25. End Product Testing can be replaced with
Real Time Release
1
Not necessarily

26. Is a product specification still necessary in
the case of Real Time Testing
Yes No
2

27. Is a product specification still necessary in
the case of Real Time Testing
2
Yes, still needed to be established &
met when tested

28. Real Time Release is an element of
Control Strategy
Yes No
3

29. 3
Yes, in line testing, on line testing &
at line testing instead of End Product
Testing
Real Time Release is an element of
Control Strategy

30. Real Time Test & In-process Testing are
the same thing
Yes No
4

31. 4
No, Real Time Testing includes
those tests that have direct impact on
decision for release of batch (CQA)
Real Time Test & In-process Testing are
the same thing

32. Can surrogate measurement be used for
Real Time Testing
Yes No
5

33. 5
Yes if correlation with an in-process
or end product specification are
established
Can surrogate measurement be used for
Real Time Testing

34. Parametric Release & Real Time Release
are same
Yes No
6

35. 6
No, Parametric Release is a type of Real Time Testing. It is
based on process data rather than testing of material or sample
for a specific attribute. Process data includes temperature,
pressure, time of terminal sterilization, physiochemical
indicators
Parametric Release & Real Time Release
are same

36. Thank you
Have a very good time