QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 500

abc Pharmaceutical comPany

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

3rd Manufacturing Facilities, Equipment, and Control (continued) Yes No N/A

16. Is there a formal record of production steps and controlled parameters

(temperature, pH, time, etc.) and quantities used in the process?   

17. Are waste materials clearly identified in proper containers?   

18. Are the ceiling fixtures and pipes free of accumulated dirt, dust, and
paint chips to prevent product contamination?   
19. Are valves and associated pipes in the production areas free of leaks?   
20. Is there a system to verify the use of only released components?

  

21. If water is used in the process, does it meet compendia requirement

for the type of water used?   

22. Are manufacturing equipment adequate in size and designed to produce
maximum batch size quality product?   
23. Is the manufacturing process controlled by computer software-validated?   

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