maintenance of equipment as required during revalidation.

Quality Assurance (QA) Team: Review and approve revalidation protocols and reports.

Procedure

1. Preparation:
   • Develop a revalidation schedule for all climatic rooms and chambers, ensuring that each unit is revalidated at least annually.
   • Prepare a revalidation protocol outlining the specific tests to be
     

     “Mastering Stability Testing for Pharmaceutical Excellence – A Comprehensive Guide for Optimum Drug Development”

     performed, acceptance criteria, and documentation requirements.
   • Ensure all necessary equipment and materials are available and calibrated prior to the revalidation process.
2. Environmental Mapping:
   • Conduct temperature and humidity mapping of the climatic rooms and chambers using calibrated data loggers.
   • Place data loggers at critical points within the chamber to ensure comprehensive coverage.
   • Run the mapping study for a sufficient period (e.g., 24-72 hours) to capture environmental variations.
   • Analyze the data to ensure all areas within the chamber meet the specified conditions.
3. Calibration Checks:
   • Verify the calibration status of all temperature and humidity sensors used within the chambers.
   • Perform calibration checks according to the manufacturer’s instructions and document the results.
   • Replace or recalibrate any sensors found to be out of specification.
4. Functional Testing:
   • Conduct functional tests to verify the performance of the climatic rooms and chambers, including:
     • Temperature and humidity control
     • Uniformity and stability of conditions
     • Alarm and monitoring systems
   • Document the results of all functional tests and compare them against acceptance criteria.
   • Address any deviations or failures immediately, including performing corrective actions and retesting as necessary.
5. Documentation and Reporting:
   • Compile all data, calibration records, and test results into a comprehensive revalidation report.
   • Ensure the report includes:
     • Revalidation protocol and schedule
     • Environmental mapping data and analysis
     • Calibration certificates and results
     • Functional test results
     • Deviations and corrective actions
   • Submit the revalidation report to the Stability Manager and QA Team for review and approval.
6. Record Keeping:
   • Maintain all revalidation reports, protocols, and supporting documents in a centralized location for easy access and review.
   • Ensure electronic data is backed up regularly and securely stored.
   • Archive records according to the facility’s document retention policy and regulatory requirements.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Revalidation Protocol
• Environmental Mapping Data
• Calibration Records
• Functional Test Results
• Revalidation Reports
• Audit Reports

References

• ICH Q1A(R2) Stability Testing of New Drug Substances and Products
• FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products

SOP Version

Version 1.0 – Effective Date: [Insert Date]