QAS-030 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 427

Key performance indicator: AIR BORNE PARTICULATE MONTHLY SUMMARY
( STERILE PLANTS)

Report for the month of

No. of Test
Performed 2

Out of
Speciication 3

Corrective
Measure 5

Cleanness Class 1 Total 4

Information provided by:

Name and signature:

Date:

Note:

1. The class of the room, for example, class 100, 1000, or 100,000.

2. Test performed for the air-borne particles.

3. If the result is out of specification.

4. Total number of particles.

5. Indicate in this column what corrective measure was taken.