QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 498

abc Pharmaceutical comPany

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

2nd Receiving Control Yes No N/A

1. Does the receiving inspection check incoming shipments to the requirement

of the purchase order, specification, and applicable drawings?   

2. Is there a list of qualified suppliers?   

3. If not, is there a procedure to prevent acceptance of material from

unqualified suppliers?   

4. Are released items properly segregated from material awaiting testing

and disposition?   

5. If multiple shipment dates of the same lot or multiple lots in one shipment

of the same item is received, is each lot received, sampled, tested, and

released independently?   

6. Is there an acceptable area and approved procedure for sampling?   

7. Do material container and receiving inspection records indicate

acceptance or rejection of incoming material?   

8. Is the rejected material adequately controlled?   

9. Are material stored properly to prevent damage and mix-up?   

10. Are materials properly identified as to their contents to avoid mix-up
in issuance?   
11. Is there a first-in first-out (FIFO) system for ingredients?   
12. Are records kept that track the date of receipt, lot number, and vendor?   

13. Are stocks reinspected and tested at intervals?   

14. Where required, is the controlled environment storage adequate

(humidity, temperature, etc.)?   

15. If receiving, release, issuance, and reject status controlled by

computer is software-validated?   

Comments :

Information provided by:

Designation:

Page 4 of 15