Calibration Procedure for Stability Chambers
Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for the calibration of stability chambers. This ensures that stability chambers are functioning correctly and maintaining the required environmental conditions for stability testing.
Scope
This SOP applies to all stability chambers used for housing stability samples, including drug substances and drug products, within the facility.
Responsibilities
- Stability Manager: Ensure proper calibration of stability chambers and compliance with regulatory guidelines.
- Stability Technicians: Perform calibration procedures as specified and ensure proper documentation.
- Quality Assurance (QA) Team: Review and approve calibration procedures and ensure adherence to regulatory standards.
Procedure
- Preparation for Calibration:
- Ensure all necessary calibration equipment (e.g., standard thermometers, hygrometers, data loggers) is calibrated and in good working condition.
- Document calibration records of the equipment used for calibration.
- Scheduling Calibration:
- Schedule calibration of stability chambers at regular intervals (e.g., quarterly, semi-annually) or as specified by regulatory guidelines and internal protocols.
- Ensure minimal disruption to ongoing stability studies during calibration.
- Calibration Procedure:
- Turn off any stability chamber alarms to avoid false alerts during calibration.
- Place calibration devices (thermometers, hygrometers) in the chamber at representative locations (top, middle, bottom).
- Allow the chamber to stabilize at the set conditions for at least 24 hours before recording data.
- Record temperature and humidity readings from both the chamber’s
sensors and the calibration devices at set intervals (e.g., every hour) for a specified duration (e.g., 24 hours).
Compare the recorded data to assess the accuracy of the chamber’s sensors.
Adjustments and Corrections:
Documentation:
Post-Calibration Procedures:
Quality Control:
- If discrepancies are found, adjust the chamber’s settings to align with the calibration device readings.
- Document any adjustments made and re-verify the chamber’s conditions post-adjustment.
- Record all calibration data in the calibration log, including date, time, personnel, equipment used, and readings.
- Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
- Turn the chamber alarms back on and ensure they are functioning correctly.
- Return the chamber to its normal operation and reintroduce stability samples if they were removed.
- Perform a final inspection to ensure the chamber is maintaining the required conditions.
- QA Team to conduct periodic audits of calibration records for compliance.
Abbreviations Used
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- RH: Relative Humidity
Documents
- Calibration Logs
- Calibration Equipment Records
- Chamber Adjustment Records
- Audit Reports
- Maintenance Records
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]