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Revalidation Procedure for Stability Chambers

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for the periodic revalidation of climatic rooms and chambers used in stability studies. This ensures that these environments consistently meet specified conditions and maintain the integrity of the stability data.

Scope

This SOP applies to all climatic rooms and chambers used for stability studies within the facility, including those used for storage under specific temperature and humidity conditions.

Responsibilities

• Stability Manager: Oversee the revalidation process and ensure compliance with regulatory requirements.
• Validation Team: Perform the revalidation activities, document results, and address any deviations.
• Maintenance Technicians: Assist with calibration and 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 performed,
     

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     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]

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