QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 528

abc Pharmaceutical comPany

SOP: QAS-032

QUALITY CONTROL LABORATORY Issue Date:

LEVEL-3

Attachment-C

ENVIRONMENTAL MONITORING

AREA PARTICULATES COUNT

Date:

freque ncy: once/week Buildin g “c”

room
no.

cleanness
class

Product/batch
in-Process activity location results

C-04 Production corridor 100000 Opposite autoclave

opposite FD Tech.R
opposite Pack. A

C-05 Syringe remaining room 100000 Center of the room

C-07 Change room-I (at work) 100000 Center of the room

C-09 Coding room 100000 Center of the room

C-10 Air lock washing 100000 Center of the room

C-11 Packaging A 100000 Center of the room

C-17 Washing area for compounding vessels 100000 Center of the room

C-19 Personnel air lock-I 100000 Center of the room

C-22 Commodity washing room

Autoclave loading

100000
100000

Near loading
Near loading

C-23 Packaging B 100000 Center of the room

Sterility testing room 100000 Center of the room

Tested by: Date:

Checked by: Date:

Signature

System & inspection officer

Corrective action taken in case of failure

CC: Production manager

Maintenance engineer (Utilities)

QA manager (in case of failure)

Antibiotic plant director (in case of failure)