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.
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
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
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
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
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
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