OR Centre for Quality Sciences

1. No Margin of Error in Drug Manufacturing
A Case Study of Sterile Operations
15 minutes talk
27 June 2020 (Saturday)
11.00 to 11.15 pm

3. Manufacturing
Human
Air
Materials Water

4. Manufacturing
Human
Air
Materials Water

5. Knowledge, Skill, Aptitude
Mucus
Skin
Vaginal & urtheral

6. Migration of Contamination liberated
during Facility Construction
Ref: Richard. L. Friedman,
US-FDA April 2005 (PDA)

7. Major
Construction In a clean room next to the
personnel entry air lock e.g.
gowning area
Production & construction
continued simultaneously

8. MFT
Contaminated
Practice unrelated to the
construction was likely the source
of contamination
Another MFT failure occurred
Bacillus specie identified

9. MFT
Contaminated
Spore forming bacteria …
Bacillus specie identified
?

10. 0.5 x 2.5 um, Rod shaped, G +ve
Tetanolysin & Tetanospasmin
Blocks release of inhibitory
neurotransmitters Glycine & GABA at
motor nerve endings

11. Firm did not adequately assess the
risk posed by the construction
activities
Production system was the
most deficient
Failure of QMS to evaluate impact of
change in normal & qualified condition

12. Many sterility failures & MFT failures
have been attributed to
contamination from nearby construction
Evaluate carefully, move carefully,
be vigilant always
Moving of wall is a common culprit in
the location of spore formers into the
clean room environment

13. Thanks