QAS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 281

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SOP No.:
Issued on:
Revision No.:
Initiator name:

6. Are appropriate exhaust and vacuum systems employed in operations to minimize air
contamination?
7. Are equipment cleaning and use logs being maintained?
8. Are preclearance procedures employed to prevent packaging and labeling mix-ups?
9. Are the batch records kept at the work stations during the entire operation? Are the direc-
tions strictly followed?
10. Have time limitations on the holding of processing and in-process items been established
and are they being adhered to?
11. Are changes to the issued batch records approved prior to the start of work and docu-
mented on the batch records?
12. Are proper gowning techniques and coverings employed?
13. Does the production employed use the acceptable techniques?
14. Are bagged or boxed components stored on the floor?
15. Are lubricants and coolants controlled properly such that they cannot come in contact with
product containers, closures, and in-process materials of finished products?
16. Are packaging lines specially or physically separated in a manner designed to prevent
mix-ups?

17. Are recorded charts used on time, temperature and pressure monitored processes?

PACKAGING, SHIPPING, AND DISTRIBUTION

1. Do packing and shipping records identify the individuals performing and inspecting the
shipping operations?

2. Are adequate storage facilities available and in use to safeguard the quality of the product
between final acceptance and shipping?

3. Is a rotated stock system employed to assure that the oldest approved devices are shipped
first?

4. Are the packing and shipping containers acceptable to protect the product?

5. Is there a system to assure that only products approved for released are distributed?

6. Do distribution records indicate the location of:

a. The name and address of the consignee?

b. The date shipped?

c. The name and quantity of the item?

d. The control numbers of the item?

FINAL RELEASE

1. Is there a final inspection performed by quality control on a batch-by-batch basis?

2. Does quality control have written procedures to assure that production records are reviewed?

3. Is there thorough investigation of any discrepancies found during the final review of the
production documents?

4. Is the product checked for correct expiration dating?

5. Are records of inspection and data maintained?

6. Is there a classification of defects?

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