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