QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 497

abc Pharmaceutical comPany

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

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

1. Are customer specifications reviewed by quality control 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 purchase order due dates verified against a production schedule

before the company sends material to the customer?   

4. Is there an adequate long-term capacity plan for the drug substance?   

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

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

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

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

manufacturing site, lead time, specification, process, or acceptance criteria?   

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

manner?   

9. Does the company have current and applicable SOPs on supplier audit

and internal audit?   

Comments :

Information provided by:

Designation:

Page 3 of 15