Diversified Scenarios - Part 2/4

1. Diversified Scenarios
(Part 2/4)
Training Session by
OR Centre for Quality Sciences
Obaid Ali & Roohi B. Obaid
Good Manufacturing Practices (GMP) of the 21st Century
04 April 2021, Hotel Marriott Karachi

2. Temperature Control lost for sometime
during supply chain?
Scenario 1

3. Scenario 2
Non-sterile Initially Fail
Pass after 2
weeks

4. Scenario 2
Non-sterile Initially Fail
Pass after 2
weeks
Its not only fail but Quality System is now under
microscopic examination

5. No
Anti-microbial effectiveness test
Preservative must not be used as a substitute to GMP
Appropriate procedure to prevent objectionable
microorganisms in non-sterile products
Preservative is to reduce the viable microbial
population

6. No
Preservative may not be used to reduce initial OOS
result
Failure to meet established conditions must be
rejected
Preservative is used to reduce bio-burden of a multi-
dose formulation
Rejection is not an option but obligation

7. No
… to reduce microorganisms introduced during
manufacturing by addition of preservative
It is an opportunity to see & review manufacturing
process & identify the weakest area
Holding for 2 weeks is a great question that provides
opportunity …
Look back & see desensitization of Quality
Management System

8. 2X mg X mg
1/2X
mg
Scenario 3

9. 2X mg X mg
1/2X
mg
Scenario 3

10. Scenario 4

11. Sterilization is a process to kill all organisms.
Every injectable must be sterile

12. Sterilization is a process to kill all organisms.
Every injectable must be sterile
Terminal Sterilization & Aseptic Processing are
used to manufacture sterile drugs

13. Sterilization is a process to kill all organisms.
Every injectable must be sterile
Terminal Sterilization & Aseptic Processing are
used to manufacture sterile drugs
Autoclave, oven, radiation, etc. are used for
terminal sterilization.

14. Sterilization is a process to kill all organisms.
Every injectable must be sterile
In aseptic process, End product is not terminally
sterilized because it is manufactured in an
environment that is controlled for microbes.
Terminal Sterilization & Aseptic Processing are
used to manufacture sterile drugs
Autoclave, oven, radiation, etc. are used for
terminal sterilization.

15. Sterilization is a process to kill all organisms.
Every injectable must be sterile
In aseptic process, End product is not terminally
sterilized because it is manufactured in an
environment that is controlled for microbes.
Terminal Sterilization & Aseptic Processing are
used to manufacture sterile drugs
Autoclave, oven, radiation, etc. are used for
terminal sterilization.
Can terminal sterilization be replaced with
aseptic manufacturing technique?

16. Scenario 5

17. Drugs are generally taken by the same oral route
as food. They are called Oral Dosage Forms

18. Drugs are generally taken by the same oral route
as food. They are called Oral Dosage Forms
Our foods are not tested for microbial growth &
we use oral route for drinking and eating

19. Drugs are generally taken by the same oral route
as food. They are called Oral Dosage Forms
Our foods are not tested for microbial growth &
we use oral route for drinking and eating
Do we need to check microbial burden in Oral Dosage Forms?

20. Scenario 6

21. Protective gowns are washed through contract
washing services

22. Protective gowns are washed through contract
washing services
Washing facility is a multipurpose washing
facility and offer cleaning services of clothes.

23. Protective gowns are washed through contract
washing services
Washing facility is a multipurpose washing
facility and offer cleaning services of clothes.
Dozens of different industries have contract
with them for uniform cleaning of their staff

24. Protective gowns are washed through contract
washing services
Washing facility is a multipurpose washing
facility and offer cleaning services of clothes.
Is this practice acceptable within the intent of GMP?
Dozens of different industries have contract
with them for uniform cleaning of their staff

25. Scenario 7

26. If someone is efficient to dispense 50 materials
of 5 batches of different products altogether
without any error

27. If someone is efficient to dispense 50 materials
of 5 batches of different products altogether
without any error
Does GMP Allow?

28. Scenario
08
Dedicated facility, Segregated facility, Self
contained facility,
Why not in common facility?

29. Scenario
09
Easy to Clean & Easy to Maintain, whether it is
equipment or facility etc.
What is difficult & what is not easy?
Scenario 9

30. Scenario
10
Suitable number of individuals to perform job
What is not suitable?

31. Scenario
11
At number of places we see the use of words
Adequate or Appropriate or Suitable
Do we need to perform risk evaluation too
demonstrate the intent of words?

32. Thanks