Standard Operating Procedure for Microbial Limit Testing

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for determining the microbial load in pharmaceutical products, ensuring compliance with regulatory requirements and product safety standards.

Scope

This SOP applies to all personnel involved in microbial limit testing procedures within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for performing microbial limit testing according to the procedures outlined in this SOP.
• Production Personnel: Responsible for providing samples for microbial limit testing and ensuring proper documentation.

Procedure

1. Sample Preparation:
   • Obtain representative samples of the pharmaceutical product to be tested.
   • Prepare sample solutions or suspensions according to specified methods and dilutions.
2. Enumeration of Microorganisms:
   • Inoculate appropriate culture media with the prepared samples using aseptic techniques.
   • Incubate cultures under specified conditions to promote microbial growth.
   • Count microbial colonies using suitable enumeration techniques such as pour plate or membrane filtration.
3. Identification of Microorganisms:
   • Perform biochemical tests or other identification methods to characterize microbial isolates, if required.
   • Record and interpret identification results as per regulatory guidelines.
4. Calculation of Microbial Limits:
   • Calculate the microbial load in the pharmaceutical product based on the number of colonies observed and the dilution factor used.
   • Compare microbial counts with established acceptance criteria and regulatory limits.
5. Documentation and Reporting:
   • Document all test results, observations, and calculations accurately and legibly.
   • Report microbial limit testing results to the appropriate personnel and maintain records as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Microbial Limit Testing Records
• Incubation Log
• Identification Results

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

SOP Version

Version 1.0