Tutorial for Discussion

1. Regulatory Science of
Sterile Manufacturing Process
Obaid Ali
August 2018
Case Study - 06

2. Extensive Human Aseptic Intervention
Ref: Richard. L. Friedman,
US-FDAApril 2005 (PDA)

3. MFT
Contaminated
60% of units run in MFT found
contaminated
The firm implemented minor
corrections to their satisfaction

4. 3
MFT Results
No contamination
Heavily contamination (95%)
No contamination

5. Skin borne
Stapylococcus specie
Sterility failure 6 months before

6. Skin borne Stapylococcus specie
Facultative anaerobe, G +ve Cocci
… A common pathogen in humans, mostly it is
hospital acquired infection

7. Multiple human interventions
Aseptic gowning was inadequate

8. Personnel training & supervisory oversight operation
Aseptic gowning & adequacy of process design
Production System & Quality System
?
?

9. Perception is used & appropriate
investigation not done
Considered as anomalous episode that could b
prevented by implementing some minor correction

10. Upon failure, 3 consecutive lots should be
passed but they did not bother
Moving potential without knowledge that non-
sterility problem still exist was actual concern

11. Design flaw in gownng
& human interventions
were the potential
source of
contamination
Lesson