Monitoring and Management of Temperature and Humidity Records
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish the process for reviewing and controlling temperature and humidity recording charts used in stability studies. This ensures that environmental conditions are consistently monitored, recorded accurately, and deviations are promptly addressed to maintain the integrity of the stability data.
Scope
This SOP applies to all stability studies conducted within the facility, covering all types of stability chambers and storage conditions used for drug products.
Responsibilities
- Stability Manager: Oversee the review and control process of temperature and humidity recording charts, ensuring compliance with regulatory requirements.
- Stability Technicians: Perform daily
monitoring, recording, and initial review of temperature and humidity charts.
Maintenance Technicians: Ensure stability chambers are functioning correctly and calibrated as per the maintenance schedule.
Quality Assurance (QA) Team: Conduct periodic reviews and audits of temperature and humidity records, ensuring proper documentation practices are followed.
Procedure
- Monitoring and Recording:
- Install calibrated temperature and humidity sensors in each stability chamber to continuously monitor environmental conditions.
- Utilize automated data logging systems to record temperature and humidity at predetermined intervals (e.g., every 15 minutes).
- Perform daily manual checks to verify the accuracy of automated recordings and log the readings in a designated logbook or electronic system.
- Record any deviations from the specified conditions immediately and notify the Stability Manager.
- Daily Review:
- Stability Technicians should review the temperature and humidity recording charts daily to ensure data accuracy and completeness.
- Verify that all recorded data fall within specified ranges and document any deviations.
- Sign and date the charts to confirm the review has been conducted.
- Weekly Review:
- The Stability Manager should conduct a weekly review of the recording charts to identify any trends or recurring deviations.
- Ensure that all deviations have been documented and addressed according to the SOP.
- Sign and date the charts to confirm the weekly review has been conducted.
- Monthly Review and Reporting:
- Conduct a comprehensive review of recorded data on a monthly basis, comparing manual and automated records for consistency.
- Prepare a summary report of the monthly review, highlighting any issues, trends, and corrective actions taken.
- Submit the summary report to the Stability Manager and QA Team for review and approval.
- Handling Deviations:
- Document any deviation from specified temperature and humidity conditions, including date, time, duration, and extent of the deviation.
- Investigate the cause of the deviation and take immediate corrective actions to restore the specified conditions.
- Assess the impact of the deviation on the stability study and document the findings.
- Report the deviation and the impact assessment to the Stability Manager and QA Team for review and approval.
- Record Keeping:
- Maintain all temperature and humidity recording charts, manual logs, deviation reports, and summary reports 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
- Stability Protocol
- Temperature and Humidity Recording Charts
- Automated Data Logs
- Deviation Reports
- Monthly Summary 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]