and ensure adherence to regulatory standards.

Procedure

1. Preparation for Monitoring:
   • Ensure all monitoring equipment (e.g., thermometers, hygrometers, data loggers) is calibrated and in good working condition.
   • Document calibration records and ensure traceability.
2. Installation of Monitoring Devices:
   • Place monitoring devices in stability chambers and storage units
     

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     at strategic locations to accurately capture temperature and humidity data.
   • Ensure devices are placed in areas most representative of the chamber conditions, avoiding proximity to cooling or heating elements.
3. Monitoring Frequency:
   • Set up continuous monitoring using data loggers to record storage conditions at predetermined intervals (e.g., every 5 minutes).
   • Perform manual checks and record temperature and humidity data at least twice daily.
4. Data Recording and Documentation:
   • Download data from data loggers at regular intervals (e.g., weekly) and review for compliance with specified conditions.
   • Document manual readings in storage condition logs and ensure accurate and complete records.
5. Review of Monitoring Data:
   • Stability Manager to review data logs weekly to identify any trends or deviations from specified conditions.
   • QA Team to conduct periodic audits of monitoring records for compliance.
6. Handling Deviations:
   • Investigate any deviations from specified conditions immediately.
   • Document the deviation, including the date, time, duration, and potential impact on stability samples.
   • Implement corrective actions to address the root cause and prevent recurrence.
   • Record corrective actions taken and review effectiveness.
7. Equipment Maintenance:
   • Perform regular maintenance on monitoring devices and storage units according to manufacturer recommendations and internal SOPs.
   • Document maintenance activities and ensure all equipment is in optimal working condition.
8. Reporting:
   • Compile monthly reports summarizing storage condition data and any deviations observed.
   • Submit reports to the Stability Manager and QA Team for review.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• RH: Relative Humidity

Documents

• Storage Condition Logs
• Data Logger Records
• Calibration Records
• Maintenance Records
• Deviation Reports
• Monthly Summary 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]