Standard Operating Procedure for Microbial Limits Testing

1) Purpose

This SOP outlines the procedures for conducting microbial limits testing on pharmaceutical products to ensure they meet acceptable microbiological quality standards, ensuring product safety and compliance with regulatory requirements.

2) Scope

This SOP applies to all pharmaceutical products requiring microbial limits testing, including raw materials, in-process samples, and finished products.

3) Responsibilities

The Microbiology department is responsible for performing microbial limits 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 microbial limits testing protocol and ensure all necessary materials and equipment are available (e.g., culture media, incubators, sterile containers).
2. Verify the cleanliness and sterility of the testing environment and equipment.

4.2 Sample Collection

1. Collect samples aseptically as per the sampling plan. Ensure samples are representative of the batch and handled in a manner that prevents contamination.
2. Label the samples with all relevant information (e.g., product name, batch number, date of sampling).

4.3 Testing Method

1. Total Aerobic Microbial Count (TAMC):
   1. Prepare the test sample by diluting it in a suitable diluent.
   2. Inoculate the diluted sample onto the culture media (e.g., TSA) and incubate under specified conditions.
   3. Count the number of colony-forming units (CFUs) after the incubation period.
2. Total Yeast and Mold Count (TYMC):
   1. Prepare the test sample by diluting it in a suitable diluent.
   2. Inoculate the diluted sample onto the culture media (e.g., SDA) and incubate under specified conditions.
   3. Count the number of colony-forming units (CFUs) after the incubation period.
3. Specified Microorganisms:
   1. Prepare the test sample by diluting it in a suitable diluent.
   2. Inoculate the diluted sample onto selective media designed to isolate specific microorganisms (e.g., E. coli, Salmonella).
   3. Incubate under specified conditions and observe for the growth of specified microorganisms.

4.4 Data Analysis and Interpretation

1. Compare the CFU counts for TAMC and TYMC against the acceptance criteria defined in the testing protocol.
2. For specified microorganisms, confirm the presence or absence based on the selective media results and compare with acceptance criteria.
3. Interpret the results to determine if the product meets the microbial limits requirements.

4.5 Reporting and Documentation

1. Document all testing activities, observations, and results in the appropriate logbooks and records.
2. Prepare a microbial limits 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.

4.6 Corrective and Preventive Actions (CAPA)

1. Initiate CAPA procedures if test results indicate non-compliance with microbial limits.
2. Implement corrective actions to address the root cause of any contamination and prevent recurrence.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
TAMC: Total Aerobic Microbial Count
TYMC: Total Yeast and Mold Count
CFU: Colony-Forming Units
CAPA: Corrective and Preventive Actions

6) Documents, if any

Microbial Limits Testing Protocol, Sampling Records, Test Results Logbooks, Microbial Limits 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 Microbial Examination of Non-Sterile Products: Microbial Enumeration Tests, Ph. Eur. 2.6.13 Microbial Examination of Non-Sterile Products: Test for Specified Microorganisms

8) SOP Version

Version 1.0