QAS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 280

31.8 attachment forms

attachment a

SOP No.:

Issued on:

Revision No.:

Initiator name:

CHECKLIST FOR AUDIT

1. Does receiving inspection check incoming shipment to the requirements of the purchase
order, specifications, and applicable drawing?
2. Is there a procedure to prevent acceptance of material from unqualified suppliers?
3. Where appropriate, are material weight checks made upon receipt?
4. Do receiving inspection records reflect the reasons for rejection?
5. Are records of receiving activities properly stored?
6. Are inspected items properly segregated from the material awaiting inspection?
7. Is the inspected material adequately identified as to its acceptance or rejection?
8. Is the rejected material adequately controlled?
9. Are the sampling plans employed by quality control sufficient?
10. Is the sampling of received materials performed in a separate area, or with proper controls?
11. Are materials handled, identified, and stored in a manner that will prevent damage, con-
tamination, mix-up, and/or loss.
12. Are accountability records kept to permit traceability?

13. Are stocks reinspected and tested at intervals?

14. Is there a distinct and adequate size label room?

15. Is there label room designed to avoid mix-ups?

16. Is there a sufficient accountability system for labels?

17. Are the material storage and handling procedures documented?

18. Are there specified restrictions on authority for access to labels and other labeling?

AUDIT EXECUTION

1. Evaluate the interpretation of the SOPs with a cross section of people, that is, manager/
supervisor/operators.

2. Verify by seeking objective evidence to show compliance to the procedure.

3. Look for evidence of weakness/inconsistencies identified.

4. Evaluate over time the consistent application of procedures, that is, today, last week, and 3
months ago.

5. Verify that communications/services rendered to other departments are properly executed.

PRODUCTION/PACKAGING/IN-PROCESS CONTROL

1. Do the production employees appear to be neat, clean, suitably attired, organized, and
operating efficiently?

2. Are there written procedures for production and process control?

3. Are written procedures being followed?

4. Does the production equipment appear to be appropriately designed, constructed, and
maintained?

5. Are utensils cleaned to prevent contamination between different product usages?

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