The document discusses emerging challenges for generic drugs and regulatory science. It covers topics such as ensuring generic drugs have the same quality and ingredients as brand drugs, issues that can arise when changing dosage forms, stability testing, dissolution failures, scale-up challenges, tablet scoring techniques, supplier qualification, analytical methods, cleaning methods, reduced testing options, integrity obligations, and elemental impurities. The presentation provides an overview of these issues and signals they are open to discussion.

1. Generic Drugs & Promise of Regulatory Science
(3/3)
Obaid Ali & Roohi B. Obaid
April 08th
, 2015
Hotel Regent Plaza, Karachi

2. All Praise be to
ALLAH

3. Session 4
Emerging Challenges &
Radar Navigation
Obaid Ali, Roohi B. Obaid
Generic Drugs
Promise of Regulatory Science

4. Generic-A Great Claim

5. Generic- Perception or Reality
More than 50% drugs are fake
We do not compromise on quality
and put in 100% API
We & our kids use the same drugs,
we manufacture

6. Great Challenge with Generics

7. Dosage Form Change Over ???
Open for discussion. If you have any reference of any
developed country, it will be added knowledge.

8. Overage

9. Overage

10. Stability

11. Dissolution Failure

12. Sometimes Maths does not favor

13. Sometimes Maths does not favor

14. Sometimes Maths does not favor

15. Sometimes Maths does not favor

16. Production Scale up

17. Tablet Scoring
Scoring is not a cosmetic issue
but important …..

18. Supplier Qualification

19. Supplier Qualification

20. Analytical Method

21. Cleaning
Cleaning method should be capable to clean the
equipment appropriately up to reasonable limits in
order to ensure the forthcoming product is not
contaminated by the previous product residues or
the traces of cleaning agent used

22. Testing Waiver/ Reduced Testing

23. Integrity, Obligations Etc.

24. Integrity, Obligations Etc.

25. Footprints of knowledge is in your backyard to navigate you …
Example
Elemental impurities
Ref: Pharmaceutical Technology,
March 2015, Andrew Teasdale et al.

26. Footprints of knowledge is in your backyard to navigate you …

27. Footprints of knowledge is in your backyard to navigate you …

28. Footprints of knowledge is in your backyard to navigate you …

29. Metal solubility in product
Footprints of knowledge is in your backyard to navigate you …

30. Footprints of knowledge is in your backyard to navigate you …

31. Closing Message