QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 527

abc Pharmaceutical comPany

SOP: QAS-032

QUALITY CONTROL LABORATORY Issue Date:

LEVEL-3

Attachment-B

ENVIRONMENTAL MONITORING

AREA PARTICULATES COUNT

Date:

frequenc y: twice/week buildi ng “c”

room
no.

cleanness
class

Product/batch
in-Process activity location results

C-06 Syringe preparation 10000 Central of the room

C-07 Change room-I (at rest) 10000 Center of the room

C-08 Change room (at rest) 100 Center of the room

Change room-II (at work) 10000 Center of the room

C-12 Syringes filling remaining room 10000 Center of the room

C-18 Air lock for materials 10000 Center of the room

C-19/1 Personnel air lock-II 10000 Center of the room

C-19/2 Solution preparation 10000 Center of the room

C-20 Vials capping (LFH) 10000 Center of the room

C-25 Vials/ampoules filling remaining room 10000 Center of the room

C-28 CR/1 Unload FD 10000 Center of the room

C-31 Solution room (press box) 10000 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)