QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 529

aBc Pharmaceutical comPany

SOP No.: QAS-032
ISSUED DATE:

QUALITY CONTROL LABORATORY

ENVIRONMENTAL MONITORING

AIR SAMPLING

ANNEXURE I

Product/
batch

limit cfu/cf
of air room samPling station cleanliness result

Cartoning 100000

Bottling 10000

Capsule 10000

Tabletting 10000

Store 100000

Washing 100000

Blending saving 10000

Weighing 10000

QA 100000

Change room 100000

Washing 100000

Coating 10000

Sorting 10000

Blistering 100000

Pre-airlock 100000

Change room/1 100000

Change room/2 10000

Solution preparation 10000

Change room (2) 100000

Loading bottle 10000

Loading capsule 10000

Loading tablet 10000

Production corridor 100000

Loading tablet 100000

QC laboratory 100000

Prepared by: Date:

Tested by: Date:

Checked by: Date:

QC manager

Corrective action taken in case of failure:

CC: QA manager/production manager/maintenance engineers (Utilities)