A workshop with limited number of participants

1. Pharmaceutical Regulatory Expectations
for Complaint Handling
An Erosion to Improve
Roohi B. Obaid
20 Oct 2018 at Karachi

2. D
I
S
C
L
A
I
M
E
R
Personal Point of
View
Knowledge &
Experience
Current
Judgment
This presentation discusses science, nothing
more and nothing less

3. Complaint is a GMP attribute or GMP element?
Which is more suitable & why?
Opening Question 1

4. If a drug is manufactured in GMP environment & qualifies all
tests, is it sufficient for quality or something remains?
Opening Question 2

5. Surveillance
(Keep eyes open)
Complaints
(Grievances)
Recalls
(Pick up)
Vigilance
(Be alert)

6. GMP ….
What, why, how, when, where …

7. Quality cannot be observed by every one and/or by naked eye
Quality cannot be tested in a laboratory but has to be built in to
the product
Remember, GMP is the only answer for Quality

8. GMP Elements
(Constituents)
Premises Equipment Personnel
Materials Documentation
Qualification
&
Validation

9. GMP Systems
Quality
System
Production
System
Lab
Control
System
Facilities &
Equipment
System
Materials
System
Packaging
&
Labeling
System

10. GMP System Indicators & Attributes
(Properties)
Complaints
Recall &
Returns
Investigations
& CAPA
Internal
Audits
Reviews
Change
Management
Supplier
Qualification
Risk
Management
Deviations
Master
Maintenance
Plan
Master
Validation
Plan
Master
Training Plan
Calibration

11. Pure
Consistent
Zero Mix
Up
Drug
1 2 3
Batch after Batch
Within Batch
Time after Time

12. GMP Assures
Identity, quality &
strength of drugs
Correct procedures are
followed
Timely documented
Reviewed before release

13. Quality Safety Efficacy Identity Purity Strength

14. Complain opens Door of Inspection

15. Complaint
Let’s
Learn from mistakes
Roohi B. Obaid

16. R Receive1
RReview 2
E Evaluate3
MMaintain 4

17. Individuals
InvestigateTrained

18. Uniform
Timely
Document

19. Evaluate
Reporting is
required
Reporting is
NOT required

20. Evaluate
Investigation
is required
Investigation
is NOT
required

21. Justify
Document
Why it is not required?

22. O • Opportunity
K • Knowledge
I • Improve
Insight
Understand
Systems

23. Turn around
Go back
You might lost
something that you
may catch

24. Complaint: Have you ever done yourself ?
Please recall
Write,
If not imagine
& write

25. Uncle: I always find 25 candies of
orange, 25 of mango, 25 of apple
& 25 of banana flavor in one
packet
Uncle: This time no banana, you
know I like banana flavor, I am
depressed

26. How will you handle this
complaint?
Imagine and share the
story that can connect the
dots

27. What type of complaints you
may receive?
Please list down
1

28. What type of errors for which
you may not receive a
complaint?
Please list down
2

29. What errors can cause death of
patient or consumer & you are
more likely not to receive
complaint?
Please list down
3

30. What potential complaints you
may receive that may not have
any physiological response &
will not harm?
Please list down
4

31. Case A

32. PIC tragedy
Adulteration of pyrimethamine
About 150 deaths
Pakistan
Tragic Event

33. What do you know about this GMP tragedy1

34. What do you know about this GMP tragedy1
What happened2

35. What do you know about this GMP tragedy1
What happened2
How it was caught3

36. What do you know about this GMP tragedy1
What happened2
How it was caught3
How it was concluded4

37. What do you know about this GMP tragedy1
What happened2
How it was caught3
How it was concluded4
What actions were taken5

38. How it can be avoided6

39. How it can be avoided6
Under what scenarios the same may
happen in your facility7

40. Case B

41. Tribromo Phenol Case
J&J, Pfizer,
Huge recall
International
Event

42. What do you know about this GMP issue1

43. What do you know about this GMP issue1
What happened2

44. What do you know about this GMP issue1
What happened2
How these were caught3

45. What do you know about this GMP issue1
What happened2
How these were caught3
How these were concluded4

46. What do you know about this GMP issue1
What happened2
How these were caught3
How these were concluded4
What actions were taken5

47. How this can be avoided6

48. How this can be avoided6
Under what scenarios the same may
happen in your facility7

49. FDA writes …

50. Firm confessed
…

51. is a requirement of GMP used to
verify consistency of product
and appropriateness of existing
manufacturing process. It helps
in improvement of product and
process.
Use change for Fermentation,
not for ErosionComplaint Handling

52. Thank You