Biomedical Engineering Reference
In-Depth Information
8.5
attachment forms
Attachment 1A
SOP No.:
Issued on:
Revision No.:
Initiator name:
ABC PHARMACEUTICAL COMPANY
QC LABORATORY
MICROBIOLOGICAL MONITORING
WFI TESTING REPORT
Sampled from:
Testing date:
Sampling time:
Sampled by:
Sampling Point
TMC
LAL
Return WFI
CFU/100 mL
USP EU/mL
Supply WFI
CFU/100 mL
USP EU/mL
xxx
CFU/100 mL
USP EU/mL
xxx
CFU/100 mL
USP EU/mL
xxx
CFU/100 mL
USP EU/mL
xxx
CFU/100 mL
USP EU/mL
Action limit: TMC : 5 CFU/100 mL
LAL : NMT 0.25 USP EU/mL
Comment
:
Tested by
:
Report Date:
Checked by :
Manager QC
QC director
CC: QA
Production
Maintenance director
In case of failure
Manufacturing director
QA director
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