QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 501

abc Pharmaceutical comPany

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

4th Quality Control Yes No N/A

1. Is the impurity profile of the drug substance established and individual

impurities identified with validated methods above 0.1% level?   

2. Is USP organic volatiles and other residual solvents established for drug

substance?   

3. Does the company have an annual product review SOP?   

4. Is there a formal stability program for drug substance?   

5. Are all stability chambers and incubators controlled for specified

humidity and temperature requirements?   

6. Does the company have a SOP for complaints handling, follow-up,

documentation, and preventive action?   

7. Are all raw data properly recorded and available for verification?   

8. Does the company have SOP for handling aberrant data?   

9. Is the company capable of performing microbial testing and endotoxin

test for bulk drug substance?   

Comments :

Information provided by:

Designation:

Page 7 of 15