QAS-030 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 434

Key performance indicator: IN-PROCESS NONCOMPLIANCE/PROCESS DEVIATIONS

Report for the month of

Batch #/Number
of Batches 1

In-process
Nonconformance 2

Root
Cause 3

Corrective
Action 4

Preventive
Action 5

Product

Information provided by:

Name and signature:

Date:

Note:

1. Total number of batches manufactured in the respective dosage form area.

2. Number of nonconformances occurred during the processes.

3. If the root cause of the nonconformance was determined.

4. Brief description of corrective actions taken.

5. Brief description of preventive actions taken.