Session organized by Centre for Quality Sciences on 12 June 2022 at Hotel Marriott, Karachi

1. Connecting Dots &
Creating Big Picture
to Focus

2. GMP for Quality &
Quality for Life
Ignorance brings Disaster
Compliance is not
Choice but Obligation
Confusion Promotes Mix up
& Mix up is nothing but
Disaster
1
2
4
5
Humans Contaminate
Drugs
Feel smoke before it
appears
3 6
Connect dots & create a big picture to focus

3. GMP for Quality &
Quality for Life
1
Removing Fog to Enhance Clarity

4. GMP for Quality &
Quality for Life
1
Respect its claim
Perform as committed
Deliver benefits
Protects hope
Removing Fog to Enhance Clarity

5. Compliance is not
Choice but Obligation
2
Removing Fog to Enhance Clarity

6. Compliance is not
Choice but Obligation
2
Health is a constitutional right
Law and rules
Removing Fog to Enhance Clarity

7. Compliance is not
Choice but Obligation
2
Health is a constitutional right
Law and rules
Penalty and criminal proceedings
Removing Fog to Enhance Clarity

8. Compliance is not
Choice but Obligation
2
Drug manufactured under non-
GMP environment is an adulterated
drug and subject to penalty &
criminal proceedings
Health is a constitutional right
Law and rules
Penalty and criminal proceedings
Removing Fog to Enhance Clarity

9. Humans Contaminate
Drugs
3
Removing Fog to Enhance Clarity

10. Humans Contaminate
Drugs
3
Training & Professional Development
Removing Fog to Enhance Clarity

11. Humans Contaminate
Drugs
3
Skill, knowledge, ability, aptitude,
experience
Shed particles from skin, hair, clothes
Become source of microbial load
Ignorance, negligence, omission,
commission
Training & Professional Development
Removing Fog to Enhance Clarity

12. Ignorance brings Disaster
4
Removing Fog to Enhance Clarity

13. Ignorance brings Disaster
4
Mix up
Contaminated
Fail to deliver
Loss of potency
Etc. etc.
Removing Fog to Enhance Clarity

14. Confusion Promotes Mix up
& Mix up is nothing but
Disaster
5
Removing Fog to Enhance Clarity

15. Confusion Promotes Mix up
& Mix up is nothing but
Disaster
5
Physically safe and secure is the requirement
Removing Fog to Enhance Clarity

16. Confusion Promotes Mix up
& Mix up is nothing but
Disaster
5
Physically safe and secure is the requirement
Dedicated flow and movement control
Removing Fog to Enhance Clarity

17. Confusion Promotes Mix up
& Mix up is nothing but
Disaster
5
Free flowing
Heavy traffic
Crossing lines
Insecure and unsafe
Unattended
Physically safe and secure is the requirement
Dedicated flow and movement control
Removing Fog to Enhance Clarity

18. Feel smoke before it
appears
6
Removing Fog to Enhance Clarity

19. Feel smoke before it
appears
6
Improve certainty and protect quality
Removing Fog to Enhance Clarity

20. Feel smoke before it
appears
6
From reactive to preventive &
from preventive to predictive
Improve certainty and protect quality
Removing Fog to Enhance Clarity

21. Regulatory Methodology to
inspect manufacturing practices
of drugs is called

22. Good Manufacturing Practices
Regulatory Methodology to
inspect manufacturing practices
of drugs is called

23. Integrity & Quality
of manufactured products
for human use is protected by

24. Good Manufacturing Practices
Integrity & Quality
of manufactured products
for human use is protected by

25. Production & Control of
consistent products is ensured by

26. Good Manufacturing Practices
Production & Control of
consistent products is ensured by

27. • Documentation
• Traceability
• Trust
• Predictability
is provided by

28. Good Manufacturing Practices
• Documentation
• Traceability
• Trust
• Predictability
is provided by

29. • Identity, quality & strength of drugs
• Correct procedures are followed
• Timely documented
• Reviewed before release
is assured by

30. Good Manufacturing Practices
• Identity, quality & strength of drugs
• Correct procedures are followed
• Timely documented
• Reviewed before release
is assured by

31. 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
We know
We know

32. If a drug is manufactured in GMP
environment & qualifies all tests,
Is it sufficient for quality or something
remains?

33. Surveillance
Complaints
Recalls
Vigilance

34. Pure
Consistent
Zero Mix
Up
DRUG
1 2 3
Batch after Batch
Within Batch
Time after Time

35. Lets see from another angle

36. Doctor does not want to kill patient,
pilot does not want crash ….
But it happens sometime

37. Batch manufactured ……..
Testing completed …..
Batch history reviewed …………
But
Temperature recording of room was
found out of limit when batch was
manufactured
Can the batch be
released?