Standard Operating Procedure for Growth Promotion Testing

1) Purpose

This SOP outlines the procedures for conducting growth promotion testing to ensure that culture media used in microbiological testing is capable of supporting the growth of microorganisms, thereby ensuring the reliability and accuracy of microbiological test results.

2) Scope

This SOP applies to all culture media used for microbiological testing in the pharmaceutical laboratory.

3) Responsibilities

The Microbiology department is responsible for performing growth promotion testing. Quality Assurance (QA) is responsible for overseeing the testing process and ensuring compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the growth promotion testing protocol and ensure all necessary materials and equipment are available (e.g., culture media, incubators, reference microorganisms).
2. Verify the sterility of the testing environment and equipment.

4.2 Preparation of Media

1. Prepare the culture media according to the manufacturer’s instructions or laboratory SOPs.
2. Dispense the prepared media into appropriate containers (e.g., Petri dishes, tubes).
3. Sterilize the media as required (e.g., autoclaving).

4.3 Inoculation

1. Select the reference strains of microorganisms specified in the testing protocol (e.g., ATCC strains).
2. Inoculate the media with a small number of viable microorganisms (10-100 CFUs) from the reference strains.
3. Ensure that the inoculum is uniformly distributed over the surface of solid media or throughout the volume of liquid media.

4.4 Incubation

1. Incubate the inoculated media under conditions specified in the testing protocol (e.g., temperature, duration).

4.5 Evaluation

1. Examine the media for growth of the reference microorganisms after the incubation period.
2. Compare the growth on the test media with the expected growth characteristics (e.g., colony size, morphology) of the reference microorganisms.

4.6 Data Analysis and Interpretation

1. Record the results of the growth promotion test, including any observations of growth characteristics.
2. Interpret the results to determine if the media supports the growth of the reference microorganisms as expected.
3. If the media fails to support growth, investigate potential causes and take corrective actions.

4.7 Reporting and Documentation

1. Document all testing activities, observations, and results in the appropriate logbooks and records.
2. Prepare a growth promotion test report summarizing the findings, including any deviations or observations.
3. Review and approve the test report to ensure accuracy and compliance with regulatory requirements.

4.8 Corrective and Preventive Actions (CAPA)

1. Initiate CAPA procedures if test results indicate the media does not support the growth of reference microorganisms.
2. Implement corrective actions to address the root cause of the issue and prevent recurrence.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
CFU: Colony-Forming Units
CAPA: Corrective and Preventive Actions
ATCC: American Type Culture Collection

6) Documents, if any

Growth Promotion Testing Protocol, Culture Media Preparation Records, Test Results Logbooks, Growth Promotion Test Reports, CAPA Records

7) Reference, if any

Regulatory guidelines such as USP <61> Microbial Enumeration Tests, USP <62> Tests for Specified Microorganisms, European Pharmacopoeia (Ph. Eur.) 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests, Ph. Eur. 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms

8) SOP Version

Version 1.0