Biomedical Engineering Reference
In-Depth Information
51.9
attachment forms
abc Pharmaceutical comPany
SOP: QAS-032
QUALITY CONTROL LABORATORY
Issue Date:
LEVEL-3
Attachment-A
ENVIRONMENTAL MONITORING
AREA PARTICULATES COUNT
Date:
frequency:
daily
Building “c
”
cleanness
class
Product/batch
in-Process
room no.
activity
location
results
Syringe pass room (LFH)
100
Under LFH
Syringes filling (LFH)
100
Under LFH
Loading/unloading autoclave
100
Under LFH
Vials filling (LFH)
100
Under LFH
Ampoules filling (LFH)
100
Under LFH
Load/unload freeze dryer (LFH)
100
Under LFH
CR/1 unload FD (LFH)
100
Under LFH
Sterility testing (LFH)
100
Under LFH
Tested by:
Date:
Checked by:
Date:
Signature
QA officer
Corrective action taken in case of failure
CC:
Production manager
Maintenance engineer (Utilities)
QA manager (in case of failure)
Plant director (in case of failure)
Search WWH ::
Custom Search