Standard Operating Procedure for Microbial Enumeration Testing

1) Purpose

This SOP outlines the procedures for conducting microbial enumeration testing on pharmaceutical raw materials and products.

2) Scope

This SOP applies to microbial enumeration testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing microbial enumeration testing. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the microbial enumeration testing protocol and ensure all necessary materials and equipment are available (e.g., culture media, incubators).
2. Verify the calibration and functionality of the incubators and other testing equipment.

4.2 Sample Collection and Preparation

1. Collect representative samples of raw materials or products according to sampling procedures.
2. Prepare the samples by ensuring they are properly labeled and identified.
3. If necessary, prepare the samples by dilution or any other specified method for microbial testing.

4.3 Testing Procedure

1. Inoculate the samples onto appropriate culture media and plates using aseptic techniques.
2. Incubate the plates at appropriate temperatures and durations according to the microbial testing method.
3. Count the microbial colonies present on the plates after the incubation period.
4. Calculate the microbial count per unit quantity of the sample