Biomedical Engineering Reference
In-Depth Information
Attachment V
SOP No.:
Issued on:
Revision No.:
Initiator name:
ABC PHARMACEUTICAL COMPANY
QC LABORATORY
MICROBIOLOGICAL MONITORING
PURIFIED WATER TESTING REPORT
Sampled from:
R&D laboratory
Testing date:
...................................
Sampling time:
........................................
Sampled by:
....................................
Room No.
Sampling Points
Total Aerobic Count
Pseudomonas
245
CFU/mL
244
CFU/mL
243
CFU/mL
P.05
CFU/mL
242
CFU/mL
CFU/mL
QC washing room
CFU/mL
CFU/mL
229
CFU/mL
230
CFU/mL
231
CFU/mL
CFU/mL
232
CFU/mL
CFU/mL
Comment:
Action limits: TAC: 100 CFU/mL, Pseudomonas: Absent in 1 mL
Tested by:
Report Date:
Checked by: QC manager
QC director
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