QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 18

SOP No. QCS-008.00 Effective date: mm/dd/yyyy
Approved by:

8.1 PurPose
This SOP describes the microbiological monitoring program at ABC Pharmaceutical Company.
The SOP covers sampling, testing, and interpretation of results in the final report. The objective of
monitoring program is to provide sufficient information to control the microbiological quality of
water for its intended use.

8.2 scoPe
This SOP is intended for microbiological monitoring of water systems used in the QC laboratory as
well as in the Research and Development (R&D) laboratory.

8.3 resPonsibility

8.3.1 Qc d ePartment

8.3.1.1 microbiologist
QC microbiologist will carry out the following activities:

• Prepare the testing equipment and growth media and carry out the growth promotion test
on the used media
• Assure that testing equipment, utilities, and media are sterile and in appropriate condition
during testing
• Follow up the sampling schedule
• Assure that sampling techniques are applied appropriately
• Count and identify the microbial isolates
• Document in the inal report, the sampling techniques used and all related details including
results

8.3.1.2 supervisor
QC microbiology lab supervisor will

• Check and interpret the results
• Determine and report the out-of-speciication results
• Summarize the data

8.3.1.3 Qc/Qa director
• Evaluate and approve the results
• Review the trend analysis
• Review the cause of out-of-speciication results
• Deviations from SOP should be noted and approved by QC and QA managers

8.3.2 r&d l aBoratory
The R&D laboratory will validate the applied methodology as per the approved protocol.