What to do when the products you received are not up to the standards?

1. HANDLING OF
PRODUCT
COMPLAINT
Nazmi Liana Azmi

2. INTRODUCTION

3. 3
NATIONAL PHARMACEUTICAL
REGULATORY AGENCY
CENTRE FOR POST
REGISTRATION OF PRODUCTS &
COSMETIC CONTROL
PHARMACOVIGILANCE
SECTION
COMPLAINT
MANAGEMENT SECTION
SURVEILLANCE
SECTION
COSMETIC SECTION

4. POST MARKET
SURVEILLANCE

5. 5
REGISTRATION CRITERIA

6. 1. POST MARKET QUALITY SURVEILLACE
✘ Market sampling
✘ Laboratory analysis
✘ Label and packaging compliance
6
ACTIVITIES

7. 2. INVESTIGATION OF PRODUCT COMPLAINTS
✘ Quality defects
✘ Regulatory compliance related issues
✘ Safety & efficacy issues
7
ACTIVITIES

8. 3. SAFETY MONITORING OF PRODUCTS
✘ ADR monitoring
✘ Signal detection & risk assessment
✘ Risk communication
✘ Risk Management & research
8
ACTIVITIES

9. 9
Monitor safety profile
REGULATORY ACTIONS
GOALS
Follow up on CAPAs to
improve product quality
Remove unsafe products
from the market in
timely manner
Ensure products are of
quality

10. HANDLING OF
PRODUCT
COMPLAINTS

11. 11

12. 12
Important!
Can add in
attachment
State the quantity
involved based on
receiving (DO)
Fill up
ADR form

13. ✘ Effective tools of conducting surveillance
✘ Mainly related to quality defects
✘ When necessary, the Marketing Authorisation
Holder required to initiate RCA and propose
CAPA
13
HANDLING OF PRODUCT COMPLAINTS

14. CLASSIFICATION
OF QUALITY
DEFECTS

15. ✘ An attribute of a product or component which
may affect the QUALITY, SAFETY AND / OR
EFFICACY of the product, and / or which is NOT
IN LINE WITH THE APPROVED MARKETING
AUTHORISATION for the product
15
DEFINITION

16. 16
IN A NUTSHELL..

17. ✘ Wrong product (label & content are different)
✘ Correct product but wrong strength, with serious
medical consequences
✘ Microbial, physical / chemical contamination,
with serious medical consequences
✘ Mix up products within a pack
✘ Serious ADR which are batch / product related
17
CRITICAL QUALITY DEFECTS
(life threatening / serious health risk)

18. 18
Label on the box was
Ternolol 50 but label
on the blister was
Ternolol Tab 100mg
After investigation..

19. ✘ Mislabelling (wrong , missing text / figures)
✘ Missing / incorrect information on package insert
✘ Microbial, physical / chemical contamination, with
medical consequences
✘ Non-compliance with specification (assay, stability, fill /
weight)
✘ Insecure closure with serious medical consequences
(cytotoxics, child-resistant containers, potent product)19
MAJOR QUALITY DEFECTS
(cause illness or mistreatment but not to a
life threatening extent)

20. 20
It was discovered that one of
the constituents of the drug
referred to as an IMPURITY
WAS OUT OF RANGE
Instead of having a chemical
presence of 0.1 per cent, it stood
at 0.3 per cent, due to false
packaging.

21. ✘ Faulty packaging (wrong, missing batch number /
expiry date)
✘ Faulty closure
✘ Tablet defect/ empty blister
✘ Microbial, physical / chemical contamination which is
unlikely to have medical consequences (a strand of hair
embed in a tablet in an intact blister)
21
MINOR QUALITY DEFECTS
(are not likely to pose a significant hazard to
health)

22. 22
Tablet defects – empty
blister / broken tablet

23. 23
What is the
classification of
this defect?

24. 24
Can we do a product complaint
on similar packaging?

25. STATISTICS

26. 26

27. 27

28. 28

29. CONCLUSION
- It is the responsibility of
ALL -

30. 30
THANK YOU FOR YOUR
ATTENTION!
Any questions?
Contact me at:
nazmiliana@moh.gov.my
0179224977