QAS-030 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 435

Key performance indicator: REPROCESSING/REWORK/SORTINGS (PRODUCTION SOLID
DOSAGE)

Report for the month of

Batch
No. 2

Rework/
Sorting 3

Root
Cause 4

Corrective
Action 5

Preventive
Measure 6

Product 1

Information provided by:

Name and signature:

Date:

Note:

1. Name of product.

2. Batch number of the product.

3. Nature of rework involved.

4. Reason/root cause for re-working.

5. Brief description of the corrective action taken.

6. Brief description of the preventive action taken.