QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 37

abc Pharmaceutical comPany

LEVEL 3

PM FORM

SOP No.: QCS-008

ULTRAPURE WATER BIOBURDEN EXCURSION Issued on:

INVESTIGATION REPORT Revision No.:

Initiator name:

S. No.: ....................

Attachment B

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:

Ultrapure system temp. trends (if any): ........................................................................................
Review of the operational parameters: ........................................................................................

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 storage tank: ...................................................................................................................
Status of vent filter: .......................................................................................................................
Status of sampling valves: .............................................................................................................
Status of sampling connection (if any): ........................................................................................

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