long-term stability studies of gel formulations.

3. Responsibilities

• Engineering Department: Responsible for installation and calibration of stability chambers.
• Quality Control (QC): Responsible for placing samples and performing periodic checks.
• Quality Assurance (QA): Responsible for approval of chamber qualifications and records.

4. Accountability

The Head – Quality Assurance shall be accountable for ensuring the chamber’s compliance with regulatory requirements and study integrity.

5. Procedure

5.1 Selection and Installation

1. Select stability chambers with validated temperature and humidity control capabilities suitable for ICH Zone IVB (40°C ±2°C / 75% RH ±5%).
2. Install the chamber in a vibration-free, clean, and isolated area with backup power supply.
3. Ensure the chamber has access control to prevent unauthorized usage.

5.2 Qualification

1. Perform Installation Qualification (IQ) to verify installation as per manufacturer’s specifications.
2. Execute Operational Qualification (OQ) by challenging the chamber at defined conditions (40°C/75% RH and 30°C/65% RH).
3. Carry out Performance Qualification (PQ) by placing dummy samples and monitoring stability over 72 hours.
4. Document all qualification results in Annexure-1.

5.3 Calibration and Validation

1. Install calibrated temperature and humidity sensors (data loggers).
2. Validate temperature uniformity using thermal mapping every 6 months or after maintenance.
3. Record sensor calibration data in Annexure-2.

5.4 Alarm and Backup Systems

1. Ensure the chamber is equipped with audio-visual alarms for excursions beyond setpoints.
2. Test alarms monthly and document results.
3. Confirm the UPS (Uninterruptible Power Supply) backup is functional with monthly verification logs.

5.5 Usage and Monitoring

1. Place labeled stability samples as per approved protocol (refer SOP/GM/102/2025).
2. Monitor chamber conditions using external calibrated data loggers.
3. Review temperature and RH logs daily and retain data in the Stability Logbook (Annexure-3).

5.6 Maintenance

1. Clean chamber surfaces weekly with 70% IPA solution.
2. Perform preventive maintenance every 6 months by the vendor or engineering team.
3. Maintain a Maintenance Record Sheet (Annexure-4).

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• UPS: Uninterruptible Power Supply
• RH: Relative Humidity
• ICH: International Council for Harmonisation

7. Documents

1. Qualification Report – Annexure-1
2. Sensor Calibration Record – Annexure-2
3. Stability Chamber Monitoring Log – Annexure-3
4. Maintenance Record Sheet – Annexure-4

8. References

• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
• WHO Technical Report Series 1010
• Schedule M – Good Manufacturing Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Qualification Report Template

Test Performed	Result	Remarks	Performed By
IQ
OQ
PQ

Annexure-2: Sensor Calibration Record

Sensor ID	Last Calibration Date	Next Due Date	Calibrated By	Remarks

Annexure-3: Stability Chamber Monitoring Log

Date	Time	Temperature (°C)	RH (%)	Reviewed By	Remarks

Annexure-4: Maintenance Record Sheet

Date	Activity Performed	Performed By	Remarks
	Preventive Maintenance

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Added alarm testing and UPS monitoring	Periodic Review	QA Head