QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 508

abc Pharmaceutical comPany

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

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

30. Does the the company have seal integrity validation data for
container/closure?   
31. Does the the company have cleaning neutralization process validation?   
32. Does the the company have stability of bulk substance in the final

storage container?   

33. Does the company have failure investigation process and logic for

release for a batch manufactured in campaign?   

34. Does the company have procedure for revalidation?   

35. Is sterility test performed in-house?   

36. Does the company have qualification requirements of personnel

responsible for sterility testing?   

37. Does the company have procedure for evaluating (releasing/rejecting)

batches that fail the initial sterility tests?   

38. Does the company perform trend analysis for microbiological

monitoring in central processing area?   

39. Are all noncompendial test methods validated?   

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