Standard Operating Procedure for Maintaining Positive Control Organisms

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish procedures for maintaining positive control organisms for testing purposes in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in the maintenance and use of positive control organisms within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for maintaining positive control organisms and ensuring their proper use in testing procedures.
• Production Personnel: Responsible for following the procedures outlined in this SOP when utilizing positive control organisms for testing purposes.

Procedure

1. Selection of Positive Control Organisms:
   • Identify appropriate positive control organisms relevant to the specific tests and assays performed in the facility.
   • Consider the characteristics and requirements of each organism, including stability, viability, and relevance to the test system.
2. Procurement and Culturing:
   • Procure authenticated strains of positive control organisms from reputable culture collections or suppliers.
   • Culture and maintain positive control organisms under appropriate conditions specified for each organism, including media composition, temperature, and incubation period.
3. Storage and Maintenance:
   • Store positive control organisms in dedicated storage facilities such as refrigerators or freezers with appropriate temperature monitoring and control.
   • Regularly subculture positive control organisms to maintain viability and genetic stability.
4. Documentation:
   • Document all information related to positive control organisms, including strain details, procurement records, culture maintenance logs, and storage conditions.
   • Maintain clear and organized records to track the history and usage of positive control organisms.
5. Usage in Testing:
   • Use positive control organisms in testing procedures according to established protocols and standard operating procedures.
   • Verify the performance of positive control organisms periodically to ensure their suitability and reliability for testing purposes.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Positive Control Organism Inventory
• Culture Maintenance Logs
• Testing Protocols and Records

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Attributes of Non-sterile Pharmaceutical Products

SOP Version

Version 1.0