QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 518

SOP No. QAS-032.00 Effective date: mm/dd/yyyy
Approved by:
51.5 data revieW
• Manufacturing will compile/review the batch documents and sent to QA.
• QC will examine and send the environmental monitoring and media ill vial/ampoule
reports to QA.
• All data will be completed and reviewed within 21 days after the completion of the simula-
tion of the process.
• QA will review the media ill batch records as per SOP, QAS-111 and issue the inal
report.
51.6 media fill rePort/documentation
A. For each media fill qualification a summary report will be written including the following
information:
1. Reason for the media fill.
2. Type of media filled.
3. Date, time duration, and lot number of the media fill.
4. Filling room (re) qualification.
5. Names of the participants in the media fill.
6. Number and size of vials and/or ampoules filled as well as the type and size of closure
used.
7. Target volume of media used (volume filled per container).
8. Machine speed of the vial/ampoules filling.
9. Container/closure type and size.
10. Filter lot and catalogue number.
11. Number of units rejected and reason (vials without stoppers, ampoules failed in leak test
and initial volume adjustments only).
12. Reconciliation of the batch at each step with signature and date.
13. Number of units incubated.
14. Number of units positive.
15. Incubation time and temperature for each group of units incubated and whether any group
of units is subjected to two different temperatures during the incubation.
16. Procedures used to simulate any steps of a normal production fill.
17. Microbiological monitoring data obtained during the media-fill set-up and run.
18. Growth promotion results of the media removed from filled containers.
19. Identification of the microorganisms from any positive units and investigation of any con-
tamination events observed during media fills.
20. Length of time media was stored in holding tank prior to filtration.
21. Length of time taken to fill all containers.
22. Results of the requalifications as outlined in the acceptance criteria of the SOP.
23. Verification of media sterility.
24. Media fill unit inspection (records and reports).
25. Management review.