QAS-030 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 438

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

Report for the month of

Closed
Out 4

Nature of
Problem 2

Preventive
Measure 3 Product Batch No. Code No. Commodity 1 Yes No

Information provided by:

Name and signature:

Date:

Note:

1. Type of packaging commodity associated with the problem or breakdown.

2. Exact nature of problem/incident.

3. If a preventive measure was taken.

4. Indicate in this column by checking the appropriate word YES or NO if the incident report
was closed or still open.