Standard Operating Procedure for Monitoring Stability Chambers for Tablet Storage
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/188/2025 |
| Supersedes | SOP/TAB/188/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To outline the procedures for the monitoring of stability chambers used for the storage of tablet products, ensuring that environmental conditions (temperature, humidity, and light) are maintained within the specified limits to ensure product stability.
2. Scope
This SOP applies to all stability chambers used in the storage of tablet products at all stages of stability testing. It covers the monitoring of environmental conditions and the handling of any deviations in the stability chambers.
3. Responsibilities
- Quality Assurance (QA): Responsible for overseeing the stability chamber monitoring process, ensuring compliance with regulatory standards, and investigating deviations.
- Maintenance Team: Responsible for ensuring the proper functioning and calibration of stability chamber equipment.
- Production Team: Responsible for placing the appropriate tablet products into the stability chambers for testing and ensuring compliance with stability testing protocols.
- Regulatory Affairs: Responsible for ensuring compliance with regulatory requirements and ensuring that the monitoring process meets the guidelines of regulatory authorities.
4. Accountability
The QA Manager is accountable for ensuring the proper monitoring and documentation of environmental conditions in stability chambers, as well as investigating and correcting any deviations from the set standards.
5. Procedure
5.1 Stability Chamber Setup
- Ensure that the stability chamber is set up according to the manufacturer’s instructions and complies with regulatory standards (e.g., ICH guidelines).
- Verify that the chamber is properly calibrated to control temperature, humidity, and light levels.
- Check the stability chamber’s alarm system to ensure it is functional and that alarms are set to activate if temperature, humidity, or light deviate from set limits.
5.2 Environmental Condition Monitoring
- Monitor the environmental conditions (temperature, humidity, and light) inside the stability chamber at regular intervals, using validated monitoring equipment.
- Record the temperature, humidity, and light data at least twice daily or as specified in the stability testing plan (Annexure-1).
- Ensure that the environmental conditions are within the specified limits (e.g., 25°C ± 2°C, 60% ± 5% RH for long-term storage). For accelerated testing, ensure that conditions are appropriate as per protocol (e.g., 40°C ± 2°C, 75% ± 5% RH).
5.3 Alarm and Deviation Management
- If the environmental conditions deviate from the established limits, activate the alarm system and notify the QA department and the maintenance team immediately.
- Investigate the cause of the deviation, which may include equipment malfunction, power failure, or improper chamber setup (Annexure-2).
- Take corrective actions such as recalibrating the equipment, fixing any issues with the chamber, or moving the product to a controlled area. Document all corrective actions taken.
- Once the deviation is resolved, ensure that the stability chamber returns to the specified conditions before resuming testing.
5.4 Data Logging and Documentation
- Use automated data loggers for continuous recording of temperature, humidity, and light levels. Ensure the data loggers are calibrated and functioning properly.
- Ensure that data is downloaded and reviewed weekly to verify compliance with specified conditions. Record all monitoring data in the Stability Chamber Monitoring Log (Annexure-3).
- Retain all monitoring records for a minimum of five years or as required by regulatory guidelines.
5.5 Stability Chamber Cleaning and Maintenance
- Ensure that the stability chamber is cleaned regularly to prevent contamination of stored products. Follow the cleaning procedure outlined in the chamber’s maintenance manual.
- Schedule regular maintenance and calibration of the stability chamber as per the manufacturer’s recommendations and regulatory requirements.
- Keep a record of all maintenance activities, including any repairs or adjustments made (Annexure-4).
5.6 Reporting
- Report any deviations or issues with the stability chamber to senior management and regulatory authorities, if necessary.
- Prepare a monthly report summarizing all stability chamber activities, including environmental monitoring results, deviations, corrective actions, and any other relevant findings (Annexure-5).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- RH: Relative Humidity
- FDA: Food and Drug Administration
- ICH: International Council for Harmonisation
7. Documents
- Stability Chamber Monitoring Log (Annexure-1)
- Deviation Investigation Report (Annexure-2)
- Stability Chamber Calibration and Maintenance Log (Annexure-3)
- Stability Chamber Cleaning and Maintenance Record (Annexure-4)
- Stability Monitoring Report (Annexure-5)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ICH Q1A – Stability Testing of New Drug Substances and Products
- ISO 14644-1 – Cleanrooms and Associated Controlled Environments
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Stability Chamber Monitoring Log
| Date | Time | Temperature (°C) | Humidity (%) | Light Level | Remarks |
|---|---|---|---|---|---|
| 01/03/2026 | 10:00 AM | 22°C | 50% | Normal | No deviations |
Annexure-2: Deviation Investigation Report
| Date | Deviation Description | Corrective Action | Root Cause | Completion Date |
|---|---|---|---|---|
| 01/03/2026 | Temperature exceeded limit | Recalibrated thermostat | Sensor malfunction | 01/03/2026 |
Annexure-3: Stability Chamber Calibration and Maintenance Log
| Date | Equipment | Calibration Performed By | Next Calibration Due |
|---|---|---|---|
| 01/03/2026 | Temperature and Humidity Logger | John Doe | 01/06/2026 |
Annexure-4: Stability Chamber Cleaning and Maintenance Record
| Date | Task Performed | Performed By | Remarks |
|---|---|---|---|
| 01/03/2026 | Cleaning and inspection | Jane Smith | No issues identified |
Annexure-5: Stability Monitoring Report
| Report ID | Report Date | Parameters Monitored | Result Summary | Actions Taken |
|---|---|---|---|---|
| REP-001 | 01/03/2026 | Temperature, Humidity | All within limits | No actions needed |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated chamber monitoring procedures | Enhanced reporting and corrective actions | QA Head |