Exploring Uncertainties & Deviations CCK Discussion Forum - Sunday, 24th Nov 2019, Regent Plaza Karachi

1. An Update Knowledge on
Drug Quality
&
Manufacturing
Exploring Uncertainties & Deviations
Opening & Warm up1

3. Today’s Strategy
Opening Discussion
Phenytoin, Ritonavir, Levothyroxin
Metoprolol, Bupropion
Knowledge Cultivation

4. Today’s Strategy
Opening Discussion

5. Developmental data are assessed, pre-
approval inspections are done, quality
system works, regular inspections are
being done, in spite of that failures
and recalls occur.
Lets share what are the reasons?
Challenge
1/5

6. If all of a sudden dissolution
fails for a batch.
You apply USP method and find
that your product complies.
Can you release this batch?
Y / N
2/5

7. Quality of development is
focused on the compliance of
dissolution test given in USP or
FDA databank.
Y / N
3/5

8. Sampling time in dissolution
testing is critical. Why ?
Share
4/5

9. If dissolution method is not developed
to catch any change, you will not be
able to predict drug performance in
biological system
Remember

10. Dissolution is the only reliable
performance test.
Understanding and selection of right
method, right conditions to develop
dissolution test
Remember

11. • Raw material changes
• Equipment changes
• Process changes
• Environmental changes
• Polymorphic changes
• Stability changes
Remember

12. Slight change in release can end
up with dramatic change in
clinical response
Y / N
5/5

13. Thanks