Standard Operating Procedure for Sterility Testing

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a protocol for conducting sterility tests on pharmaceutical products to ensure compliance with regulatory requirements and product safety standards.

Scope

This SOP applies to all personnel involved in the sterility testing of pharmaceutical products within the manufacturing facility.

Responsibilities

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

Procedure

1. Sample Preparation:
   • Obtain representative samples of the pharmaceutical product to be tested.
   • Ensure proper labeling and identification of samples.
2. Inoculation of Culture Media:
   • Inoculate sterile culture media with the test sample using aseptic techniques.
3. Incubation:
   • Incubate the inoculated culture media at the appropriate temperature and duration as per regulatory requirements.
4. Microbial Examination:
   • Examine the culture media for the presence of microbial growth after the specified incubation period.
   • Perform sub-culturing and identification of any detected microbial growth.
5. Interpretation of Results:
   • Interpret the sterility test results according to predefined acceptance criteria.
   • Document the results accurately and promptly.

Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Sterility Testing Protocol
• Sterility Test Records
• Incubation Log

Reference

Pharmacopeial Forum: General Chapter Pharmaceutical Microbiology: Sterility Tests

SOP Version

Version 1.0