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 based on dilution factors and plate counts.
5. Perform microbial enumeration testing in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure that the microbial counts in the tested samples meet the specified acceptance criteria based on compendial standards or product specifications.
2. Document any deviations from acceptance criteria and investigate root causes if necessary.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a microbial enumeration testing report summarizing the findings for each batch tested.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Microbial Enumeration Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <61> Microbial Enumeration Tests, European Pharmacopoeia (Ph. Eur.) 2.6.12 Microbial Enumeration Tests

8) SOP Version

Version 1.0