QAS-030 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 467

Key performance indicator: PROBLEMS DURING PACKAGING (COMMODITIES
RELATED & OTHER BREAKDOWNS)

Report for the month of , year

Closed Out 7

Batch
Number 2

Code
Number 3

Nature of
Problem 5

Preventive
Measure 6

Product 1 Commodity 4

Yes No

Information provided by:

Name and signature:

Date:

Note:

1. Name of the finished product involved in the problem during packaging.

2. Batch number of the product.

3. Code number of the product.

4. Commodity associated with the problem, for example, bottle, cartons, labels, leaflets, and
so on.

5. Briefly add the nature of actual problem.

6. What preventive action was taken or recommended?

7. If the report closed out, mark Yes or No.