Biomedical Engineering Reference
In-Depth Information
Subjected Performance Indicator:
MICROBIOLOGICAL MONITORING OF WATER FOR
INJECTION (STERILE, BIOTECHNOLOGY, STERILE
POWDER FILLING)
Report for the month of
, year
Total number of samples:
Number of nonconformance:
Over action limit (OAL):
Too numerous to count (TNTC):
No. of Test
1
Area
Performed
Sample OAL
2
Sample TNTC
3
Remarks
4
Sterile
Sterile powder
Biotechnology
WFI plant
Information provided by:
Name and signature:
Date:
Note:
1. Total number of tests performed for each type product in sterile and biotechnology areas.
2. Number of samples found with OAL.
3. Number of samples found with “Too numerous to count.”
4. Remarks, if any.
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