Standard Operating Procedure for Microbial Strain Verification

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for verifying the identity and purity of microbial strains used in testing within the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in the procurement, storage, handling, and testing of microbial strains in the microbiology laboratory.

Responsibilities

• Microbiology Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologists: Responsible for verifying the identity and purity of microbial strains according to the procedures outlined in this SOP.
• Laboratory Technicians: Responsible for assisting with strain verification procedures and maintaining accurate records.

Procedure

1. Procurement of Microbial Strains:
   • Source microbial strains from reputable suppliers with documented quality control measures in place.
   • Verify the authenticity and integrity of incoming microbial strains upon receipt.
2. Strain Identification:
   • Perform phenotypic and genotypic characterization of microbial strains using validated methods.
   • Compare the characteristics of the test strains against reference standards or databases to confirm identity.
3. Purity Assessment:
   • Conduct purity tests to assess the presence of contaminants or mixed cultures in the microbial strains.
   • Use selective and differential media to isolate and identify any contaminants present in the strains.
4. Documentation and Record-Keeping:
   • Maintain accurate records of strain procurement, identification tests, purity assessments, and any deviations encountered.
   • Document the results of strain verification activities, including test methods, equipment used, and personnel involved.
5. Disposition of Non-Conforming Strains:
   • If microbial strains fail to meet identity or purity criteria, quarantine the affected strains and initiate investigation and corrective action procedures.
   • Dispose of non-conforming strains according to established protocols and regulatory guidelines.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Microbial Strain Verification Log
• Strain Identification Reports
• Purity Assessment Records

Reference

United States Pharmacopoeia (USP) General Chapter Microbial Control and Monitoring of Aseptic Processing Environments

SOP Version

Version 1.0