QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 38

Attachment III

SOP No.:

Issued on:

Revision No.:

Initiator name:

ABC PHARMACEUTICAL COMPANY
QC LABORATORY

MICROBIOLOGICAL MONITORING
PURIFIED TESTING REPORT

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

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

Sampling Point TMC Coliform Pseudomonas

Film coating I CFU/100 mL

Sugar coating hot CFU/100 mL

Sugar coating cold CFU/100 mL

Sample preparation hot CFU/100 mL

Sample preparation cold CFU/100 mL

Washing I hot CFU/100 mL

Washing I cold CFU/100 mL

Basement I hot CFU/100 mL

Action limit: TMC: 100 CFU/100 mL, Pseudomonas: Absent/100 mL, Coliform:
Absent/100 mL

Comment:

Tested by: Report Date:

Checked by: QC manager

QC director

CC: QA manager, production manager, water treatment in-charge
In case of failure QA director, manufacturing director, maintenance director