Standard Operating Procedure for Sterility Testing

1) Purpose

This SOP outlines the procedures for conducting sterility testing of pharmaceutical products to ensure they are free from viable contaminating microorganisms, ensuring product safety and compliance with regulatory standards.

2) Scope

This SOP applies to all sterile pharmaceutical products manufactured and tested within the facility, including finished products, raw materials, and in-process samples.

3) Responsibilities

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

4.2 Sampling

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. Membrane Filtration Method:
   1. Filter the test sample through a membrane filter that retains microorganisms.
   2. Transfer the membrane filter to the culture media and incubate.
2. Direct Inoculation Method:
   1. Inoculate the test sample directly into the culture media.
   2. Incubate the inoculated media under specified conditions.
3. Ensure that positive and negative controls are included in each sterility test batch to verify the validity of the test.

4.4 Incubation

1. Incubate the test samples in appropriate culture media under conditions specified in the sterility testing protocol (e.g., temperature, duration).
2. Monitor the incubation environment to ensure it meets the required conditions.

4.5 Observation and Results

1. Observe the samples for microbial growth at regular intervals during the incubation period.
2. Record any observations of microbial growth, including the time and nature of the growth.
3. Interpret the results based on the presence or absence of microbial growth in the test samples.

4.6 Documentation and Reporting

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

4.7 Corrective and Preventive Actions (CAPA)

1. Initiate CAPA procedures if test results indicate contamination or other issues.
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
CAPA: Corrective and Preventive Actions

6) Documents, if any

Sterility Testing Protocol, Sampling Records, Incubation Records, Sterility Test Reports, CAPA Records

7) Reference, if any

Regulatory guidelines such as USP <71> Sterility Tests, European Pharmacopoeia (Ph. Eur.) 2.6.1 Sterility, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0