Standard Operating Procedure for Microbial Monitoring

1) Purpose

The purpose of this SOP is to establish a standardized procedure for performing microbial monitoring in the manufacturing environment to ensure control over microbial contamination.

2) Scope

This SOP applies to all areas within the facility where pharmaceutical products are manufactured, including cleanrooms and controlled environments.

3) Responsibilities

3.1 Microbiologist
– Perform microbial monitoring as per this SOP.
– Document and report monitoring results accurately.
3.2 Laboratory Supervisor
Ensure all monitoring procedures are followed.
Review and approve microbial monitoring records.
3.3 Quality Assurance (QA) Personnel
Validate microbial monitoring methods.
Ensure compliance with regulatory guidelines.

4) Procedure

4.1 Preparation
4.1.1 Clean and disinfect the sampling area and equipment.
4.1.2 Prepare sampling materials, including agar plates, swabs, and air samplers.
4.2 Sampling
4.2.1 Collect air, surface, and personnel samples at predetermined locations and frequencies.
4.2.2 Transport samples to the laboratory in sterile containers.
4.3 Testing Methods
4.3.1 Incubate samples at specified conditions (e.g., temperature, time).
4.3.2 Identify and quantify microbial colonies using appropriate microbiological techniques.
4.4 Monitoring and Documentation
4.4.1 Monitor microbial growth and record observations during the incubation period.
4.4.2 Document all sampling and testing activities in the Microbial Monitoring Log.
4.5 Reporting
4.5.1 Compile monitoring results and prepare a microbial monitoring report.
4.5.2 Submit the report to QA for review and approval.
4.6 Investigation of Deviations
4.6.1 Investigate any deviations from established limits or unexpected microbial growth.
4.6.2 Implement corrective actions and preventive measures as necessary.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Microbial Monitoring Log
– Microbial Monitoring Reports
– Equipment Calibration Records

7) Reference, if any

– United States Pharmacopeia (USP) General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments
– European Pharmacopoeia (Ph. Eur.) 2.6.12 Microbiological Monitoring of Controlled Environments

8) SOP Version

Version 1.0