Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
LEVEL 3
PM FORM
SOP No.:
WATER BIOBURDEN EXCURSION
Issued on:
INVESTIGATION REPORT
Revision No.:
Initiator name:
Attachment A
Date: ........................... Time: ...............................
Sampling point: ..............................
Used for:...............................................................
Batch No.: ...
....................................
alert limit
action limit
results
Trend: Isolated excursion
▭
Frequent excursion
▭
Attached the trend report of the point for the last 3 months
Comment upon the point during sampling: ...................................................................................
Microbial identification: .................................................................................................................
................................................................................................................
Manager QC
QA INVESTIGATION
Carried out by:
Reviewed by:
Water system temp. trends (if any):
..............................................................................................
Chemical trend reports: ................................................................................................................
Feed water pretreatment trend reports: .........................................................................................
Unusual events during sampling day: ...........................................................................................
Other environmental monitoring data in the area: .......................................................................
Water system sanitization records: ................................................................................................
Status of water pumps: ..................................................................................................................
Status of main tank: ......................................................................................................................
Status of vent filter: .......................................................................................................................
Status of automatic valves: ............................................................................................................
Status of manual valves: ...............................................................................................................
Status of sampling valves: .............................................................................................................
Status of sampling connection (if any): ........................................................................................
CIP of preparation tank: .......................................CIP of holding tank: .....................................
Status of manual valves: ...............................................................................................................
Comment: ......................................................................................................................................
......................................................................................................................................
Corrective actions
(Carried out by utilities engineer):
..............................................................
........................................................................................................................................................
Conclusion: ....................................................................................................................................
....................................................................................................................................
QC director
QA director
CC: QA file/utilities engineer/production manager/QC “microbiology”
In case of NC investigation report to be raised by QAI
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