Standard Operating Procedure for Documentation and Record-Keeping

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for documenting and maintaining records of microbiological testing activities in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in microbiological testing, including microbiologists, laboratory technicians, and quality assurance personnel.

Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologists: Responsible for documenting microbiological testing procedures, results, and any deviations observed.
• Laboratory Technicians: Responsible for maintaining accurate records of testing activities and supporting documentation.

Procedure

1. Documentation Standards:
   • Follow standardized formats and templates for documenting microbiological testing procedures and results.
   • Ensure that all documentation is legible, complete, and accurately reflects the testing activities performed.
2. Record-Keeping Requirements:
   • Maintain detailed records of sample information, including sample identification, source, collection date, and relevant specifications.
   • Document all testing activities, including sample preparation, inoculation, incubation conditions, and observations made during testing.
3. Deviation Reporting:
   • Document any deviations from established procedures or unexpected results encountered during microbiological testing.
   • Report deviations to the appropriate personnel and initiate investigation and corrective action procedures as necessary.
4. Review and Approval:
   • Ensure that all documentation is reviewed and approved by authorized personnel, such as the QA department or designated reviewers.
   • Verify that all required signatures and dates are present on documentation before filing or archiving records.
5. Record Retention:
   • Maintain microbiological testing records in a secure and organized manner, following established retention periods and regulatory requirements.
   • Archive records systematically to facilitate retrieval and ensure data integrity and traceability.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance

Documents

• Microbiological Testing Procedures
• Testing Result Forms
• Deviation Reports
• Record Retention Policy

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests

SOP Version

Version 1.0