This document contains several scenarios involving potential issues during pharmaceutical manufacturing and requests recommendations for appropriate courses of action. The scenarios include missing batch documentation, an operator falling in the manufacturing area, an unexpected increase in microbial counts during filling, exceeding the established equipment use time limit, an unrecorded deviation during manufacturing, and an external industry blast near the facility. Recommendations are sought for how to address these situations and ensure appropriate investigations, corrective actions, and batch disposition decisions are made.

1. SCENARIO AND CONSTRUCTION OF DECISION
Batch Documentation Review & Evaluation
A Last Opportunity to Whistle
Roohi B. Obaid
Karachi, the Nov17th 2018

2. Two pages of in-process monitoring sheet are missing
from a batch history. It is 70% of the data for a batch in
quantum
What should be done?
One million tablet
compressed

3. In-process test is subject to evaluation more related to
reviews of application and less to GMP
Yes or No
Please share

5. In-process

6. Operator fall down … 4 individuals rescued him in which 2 of
them reached from outside area without observing compliance.
EM was not found out of limit before & after incident. Sterility
test was found qualified.
What will be the course of action for the batch
which was under manufacturing?
Please share

7. Everything was going within control. Suddenly laboratory EM report
shocked by reporting a sharp increase in CFU of filling area. Sample
was done when batch # X was under filling. Batches Y & Z were
filled afterwards. All are pending for sterility test.
What should be done? Manufacturing should be continued or not?
If batches found sterile, can they be released? If Y is unsterile, can
we release X & Z upon passing sterility test?
Lets think

8. Maximum use of time was established 8 hours for a particular aseptic
area. Due to judgment error, it was utilized for 10 hours in filling of
injectable product.
What will be the course of action? How will you respond?
Lets think

9. Breakdown in manufacturing process. Deviation was not recorded &
investigation was not opened.
Factory was closed down due to sudden waves of city security issue
What will be the course of action? How will you respond?
Lets think

10. Blast in next door industry
What should be documented in BMR particularly, if you are
manufacturing aseptic formulations in your facility.
What will be the course of action? How will you respond?
Lets think

11. Thank You