QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 488

abc Pharmaceutical comPany

ANNEXURE C (FOR NONSTERILE)
MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE

How is a lot/batch defined?

What is the lot number system?

Approximate number of employees at the facility?

Approximate square footage of facility (including warehouse)?

Management profile:

Facility plant manager:

Quality control manager:

Production manager:

Has the FDA or DEA inspected the facility? If yes, provide dates and results.

1st Quotation/Bid System and Customer Service Yes No N/A

1. Are customer specifications reviewed by QC and/or groups

to assure the requirements can be satisfied?   

2. Is there a system to generate reliable price quotes and return

them by the due date?   

3. Are PO due dates verified against a production schedule before

confirmation to the customer?   

4. Can the vendor provide the status of customer orders in process?   

5. Is the system of control adequate to assure that current and complete

specifications are on file and will be utilized in manufacturing the item?   

6. Is there a system in place to notify customers of changes in

manufacturing site, lead time, specification, process, or acceptance

criteria?   

7. Is there a system to handle customer complaints and respond in a

timely manner?   

8. Does the firm have current and applicable SOP on supplier audit and

internal audit?   

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