QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 39

Attachment IV

SOP No.:

Issued on:

Revision No.:

Initiator name:

ABC PHARMACEUTICAL COMPANY
QC LABORATORY

MICROBIOLOGICAL MONITORING
PURIFIED WATER TESTING REPORT

Sampled from: Semisolid dosage plant Testing date: ..............................................

Sampling time: ........................................ Sampled by: ..............................................

Room No. Sampling Point Total Aerobic Count Coliform Pseudomonas

Outlet CFU/100 mL

SILOS

Inlet CFU/100 mL

01 VALVE 1 CFU/100 mL

Preparation

01 VALVE 2 CFU/100 mL

01 VALVE 1 CFU/100 mL

Washing

01 VALVE 2 CFU/100 mL

Sample 1 CFU/100 mL

Semisolid
Manufacturing

Sample 2 CFU/100 mL

Comment:

Action Limits: TAC: 20 CFU/100 mL, Pseudomonas & Coliform: Absent in 100 mL

Tested by: Report Date:

Checked by: QC manager

QC director