CCK Technical (GMP & SMO) Groups Workshop

1. Design Key to Unlock GMP Understanding
Obaid Ali & Roohi Obaid
31 Mar 2019

2. Align Actions & Expectations
on the same line
Lets try to

3. It was OTC
Each batch
was not tested

4. We stopped
Each batch
was not tested

5. We revised
Each batch
was not tested

6. How things are moving around
See

7. Manufacturer recalled the product & found 36
containers of particular lot contaminated with mold
Complaints not always documented
Chemical smell, complaint of molds, stinging for the
cream, labeled (use on newborns & on broken skin)
?
Situation

8. Retroscopic and
independent review
Regulatory Concern

9. Why every complaint was not documented?
Why investigation was not extended to other lots?
Where is risk assessment of all marketed drugs?
How would you justify the scope of investigation?
How would you justify the sufficiency of CAPA?
Regulatory Concern

10. Comprehensive
independent reviewRegulatory directions

11. Material System
1. Are all container, closure and ingredients
from each suppliers qualified?
2. Are their assigned expiration or retest date
appropriate?
3. Are material controls adequate at your end
Regulatory directions

12. Comprehensive
independent assessmentRegulatory directions

13. Over all system
1. Responsible to investigate deviation?
2. Responsible to investigate atypical events?
3. Responsible to investigate complaints?
Regulatory directions

14. Over all system
1. Responsible to investigate failures?
2. Responsible to investigate OOS?
3. Responsible to investigate OOT?
Regulatory directions

15. CAPA should indicate
1. Improvement in investigation
competencies
2. Improvement in investigating root cause
analysis
3. Improvement in Quality Unit oversight
4. Improvement in evaluating CAPA
effectiveness ….. Etc.
Regulatory directions

16. Complete assessmentRegulatory directions

17. Documentation System
1. Throughout manufacturing operations
2. Throughout laboratory operations
3. Remediate accuracy of old record
4. Sufficiency & effectiveness Etc ….
Regulatory directions

18. GMP revolves around

19. Consistency

20. Consistency
Mix up

21. Consistency
Mix up
Contamination

22. Consistency
Mix up
Contamination
Strength

23. Consistency
Mix up
Contamination
Strength
Pure

24. Consistency
Mix up
Contamination
Strength
Traceability
Integrity
Pure

25. Cosmetics
Hospitalization
Death

26. GMP Elements
Premises Equipment Personnel Materials
Documentation
Qualification &
Validation
Etc.

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

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

29. one scenario (connected dots) that
may end up with consequences
Share

30. Premises
?

31. Equipment
?

32. Personnel
?

33. Materials
?

34. Documentation
?

35. Qualification
?

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

37. Production
?

38. Lab Control
?

39. Equipment & Facilities
?

40. Materials
?

41. Packaging & Labeling
?

42. Quality
?

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

44. Complaints
?

45. Recall
?

46. Investigations & CAPA
?

47. Internal Audits
?

48. Reviews
?

49. Change Management
?

50. Supplier Qualification
?

51. Risk Management
?

52. Deviations
?

53. Maintenance Plan
?

54. Validation Plan
?

55. Training Plan
?

56. Calibration
?

57. Thank You