More than 400 participants represented dozens of manufacturing companies with diversified educational background & experience attended throughout the day with active participation in discussion forum of Regulatory & Quality Sciences.

1. Sunday, 01 April 2018 at ICCBS, University of Karachi

2. Lets be trained to Learn, Un-learn & Re-learn
Thank You
Warm Welcome in CCK Discussion Forum

3. Thank You We have deepest regards for your personal
time of Sunday in learning & building society

4. Thank You
Our Volunteers, Speakers
& all of you

5. Petition of the Day: Quality & Regulatory Sciences;
An Ultimate Destination to Reduce Barriers &
Expand Opportunities in Progress

6. 1
Highly qualified people are engaged
Learning based industry

7. 2
85% are < 15 year experience
Expanding & growing interest

8. 2
85% are < 15 year experience
Expanding & growing interest

9. 2
85% are < 15 year experience
Expanding & growing interest
Strength, Ability
& Determination

10. Reason to have concern

11. 3
Particles Contaminated

12. 3
Particles Contaminated

13. 3
Particles Contaminated
> 1 million liter injectable solution
recalled in a year in US

14. 3
Take a deep breath & imagine, have we recalled ?
Particles Contaminated
> 1 million liter injectable solution
recalled in a year in US

15. 3
Take a deep breath & imagine, have we recalled ?
Where it has gone? It is not in drain but in your vein
Particles Contaminated
> 1 million liter injectable solution
recalled in a year in US

16. When life is everything
Risk

17. Free access to information …. Globalization at its best
……… High moral & social acceptance

18. 4
Emergence & Evolution around
All options are open to progress
Be honest …..
Opportunities are expanding & barriers are reducing

19. Lets not only have a vision, but have a
spirit to design the dream
Get up & make speed fastest to chase your dream and
footsteps of success

20. The quality of drug indirectly relates to the
willingness of manufacturer, commercial
supplier, physician & society
Quality of drugs directly relates to the quality of
Regulatory Services

21. Its time to have a quick participation &
take a clear position

22. Identify more appropriate word please
Me, you & everyone
has to participate

23. Good Manufacturing Practices (GMP)
Its about ?
Evenness
1
Reliability
2
Consistency
3
Harmony
4

24. Good Manufacturing Practices (GMP)
Its about ?
Evenness
1
Reliability
2
Consistency
3
Harmony
4

25. Good Manufacturing Practices (GMP)
Its about ?
Confusion
1
Mix up
2
Over lapping
3
Distract
4

26. Good Manufacturing Practices (GMP)
Its about ?
Confusion
1
Mix up
2
Over lapping
3
Distract
4

27. Good Manufacturing Practices (GMP)
Its about ?
Extra pure
1
Impure
2
Contamination
3
Dirty
4

28. Good Manufacturing Practices (GMP)
Its about ?
Extra pure
1
Impure
2
Contamination
3
Dirty
4

29. The intent of
GMP
Its talk about …
Consistency
Contamination
Mix up
I
N
T
E
G
R
I
T
Y

30. Creating and building a
CULTURE
of learning, unlearning &
relearning

31. Wish you good luck
Have a very good learning and a worthy day

32. Interactive Exercise & Discussion with Experts

33. Lets discuss Phenomena, Events and Situations

36. Situation

37. Antiseptics are
used to clean skin
such as swabs,
cleansing pads
Situation

38. Antiseptics are
used to clean skin
such as swabs,
cleansing pads
It is powerful
against organisms
& saves from
infection
Situation

39. Antiseptics are
used to clean skin
such as swabs,
cleansing pads
It is powerful
against organisms
& saves from
infection
Should we have
concern for its
manufacturing
with regard to
microbes
Situation

40. Yes
No
Should we have CONCERN for manufacturing
of antiseptics with regard to microbial control
during manufacturing

41. Yes
Incidence prove contamination
of microorganisms
Substandard manufacturing may
cause contamination
Safety risk of infection

42. Phenomena
Sampling of
powder blends is a
matter of great
concernYes No

43. Yes
Sampling plan should be scientifically sound &
representative of batch under test
Adequacy of mixing needs to be demonstrated by
regulation
Variability of location is a critical component of FG &
need to be evaluated
Science & risk based approach

44. Yes
Adequacy of blend mixing …. Prove it
Suitable juncture in manufacturing process from
where sampling was done
Prove that no difference exist between locations of
blending
How would you prove that it will not adversely
impact on the product performance

45. Yes
Powder thief has limitations and drawbacks
May cause disturbance to the powder blend
Powder segregation & sampling error
But widely used due to reliability in many cases

46. Yes
More innovative approaches like PAT
Reliability of the sampling method through evaluation
as a part of AMV

47. Situation
A non-sterile product
containing anti-
microbial preservative
in formulation

48. Situation
A non-sterile product
containing anti-
microbial preservative
in formulation
Got Out of
Specification for
total aerobic
plate count

49. Situation
A non-sterile product
containing anti-
microbial preservative
in formulation
Got Out of
Specification for
total aerobic
plate count
Found within
specifications 2 weeks
later

50. Situation
Yes No
Non-sterile Initially Fail
Pass after 2
weeks
Batch Release?

51. 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

52. 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

53. 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

54. Thank You We have deepest regards for your personal
time of Sunday in learning & building society

55. Thank You
Our Volunteers, Speakers
& all of you