QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 507

abc Pharmaceutical comPany

ANNEXURE D (FOR STERILE)
STERILE BULK MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE

9th Sterile Bulk Manufacturer (continued) Yes No N/A

14. Does the company have a sanitization qualification program?   

15. Does the company have filter selection criteria and filtration

validation program?   

16. Does the company have completed filter validation report for sterilizing

filter with the drug substance?   

17. Does the company perform integrity testing of sterilizing filters?   

18. Are sterilizing filters changed after completion of each production lot?   

19. If filters(s) are not changed, does the the company have justification for

intergrity of the filter for the time periods utilized (multiple batch usage)

and data to show “grow through” has not occurred?   

20. Is the equipment used in processing of sterile bulk drug phase sterilized

with validated process?   

21. Is the sanitization process of equipment, transfer lines performed rather

than steam sterilization?   

22. Has the company determine the low spots or does it monitor at discharge
during validation?   
23. Does the company have equipment maintenance log for sterilizing system?   
24. Does the company use rodac or surface plates for determination of level

of contamination?   

25. Does the company have procedure for sampling of critical sufaces such
as operator's gloves, surface of equipment?   
26. If reprocessing steps are performed, is it validated and included in DMF?   

27. Does the company use WFI in the final critical processing steps?   

28. Is the WFI system validated?   

29. Is the WFI monitored daily against compendial requirement?   

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