QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 499

abc Pharmaceutical comPany

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

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

1. Are the items being manufactured identifiable throughout the operation?   

2. Are pipes labeled/color coded to show contents and flow direction?   

3. Are different grades of the same chemical distinguishable in

manufacturing to prevent mix-up?   

4. Are the manufacturing operations orderly in flow and organization?   

5. Are the manufacturing processes and facilities adequate to produce

quality products?   

6. Are lubricants and nonproduction materials properly controlled to

prevent product contamination?   

7. If drums are recycled from clients, are they cleaned via validated cleaning

procedure, visually inspected, and material tested before use?   

8. Are manufacturing equipment and utensils properly cleaned with a

validated process between usages?   

9. Does the lot number reflect one homogeneous production run?   

10. Are the manufacturing procedures formalized, controlled, and validated?   

11. Is there a formal procedure for deviations to normal practice?   

12. Are there formal validated procedures for the handling of rework?   

Is it submitted in DMF?   

13. Are current specifications readily accessible for the employees?   

14. Are production areas that are very dusty or unique in regard to

contamination properly controlled with exhaust systems or other

methods of decontamination?   

15. Are any special requirements for specific operator apparel (masks,

gowns, etc.) being violated?   

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