Tutorial for Discussion

1. Regulatory Science of
Sterile Manufacturing Process
Obaid Ali
August 2018
Case Study - 07

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

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

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

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

6. 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

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