Dr. Obaid Ali leads an interactive discussion on scenarios related to quality risk management in pharmaceutical manufacturing. The scenarios cover situations like a sudden stop in API supply, equipment failure, sterility testing failure, mixing up drug products during dispensing, using the wrong color in tablet production, and using bulk material past the validated holding time. Participants are asked to consider whether the processes can continue as planned or if corrective action is needed in each case, engaging in active discussion around quality risk management decisions.

1. Interactive Opening Discussion
with Case Studies
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
Discussion Forum on
ICH-Q9

2. Lets have a look at some scenarios
Your active participation is required

5. Scenario - 1
Suddenly supply
of an API is
stopped
Can we change source of API

6. Yes No

7. Scenario - 2
Fluid bed dryer
suddenly got out
of order
Can we use tray dryer

8. Yes No

9. Scenario - 3
Sterility fails of
Injection
Metronidazole
Can we autoclave again

10. Yes No

11. Scenario - 4
1 drum of
Ofloxacin was
dispensed
instead of
Norfloxacin
What’s the harm, both belong
to the same class & have same
strength i.e. 400 mg
Can it be used in
manufacturing

12. Yes No

13. Scenario - 5
5 & 10 mg have
different color of
tablet
Wrong color is
used in tablet
Can we ignore it

14. Yes No

15. Scenario - 6
Bulk holding
time study not
demonstrated for
more than one
week
Can in any case the bulk
material be used after 07 days

16. Yes No

17. Thank you
Have a very good time