Standard Operating Procedure for Growth Promotion

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for ensuring the efficacy of microbiological growth media used in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in growth promotion 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 growth promotion testing according to the procedures outlined in this SOP.
• Production Personnel: Responsible for providing samples for growth promotion testing and ensuring proper documentation.

Procedure

1. Selection of Test Microorganisms:
   • Select appropriate microorganisms known to be indicative of the growth properties of the media being tested.
2. Preparation of Inoculum:
   • Prepare inoculum from pure cultures of selected test microorganisms.
   • Adjust the inoculum to a specified concentration suitable for inoculation.
3. Inoculation of Media:
   • Inoculate each type of growth media with the prepared inoculum using aseptic techniques.
   • Ensure proper distribution of the inoculum on the surface of the media.
4. Incubation:
   • Incubate the inoculated media under appropriate conditions (temperature, duration) for microbial growth.
   • Monitor the media for signs of microbial growth during the incubation period.
5. Examination and Interpretation:
   • Examine the incubated media for the presence of characteristic microbial growth.
   • Record observations and interpret results based on predefined acceptance criteria.
6. Documentation and Reporting:
   • Document all test results, observations, and interpretations accurately and legibly.
   • Report growth promotion testing results to the appropriate personnel and maintain records as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Growth Promotion Testing Records
• Inoculum Preparation Log
• Incubation Parameters

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Attributes of Nonsterile Pharmaceutical Products

SOP Version

Version 1.0