assurance.

3. Responsibilities

• Quality Control (QC): Responsible for conducting and recording stability tests.
• Stability Study Coordinator: Responsible for initiating, monitoring, and managing all long-term stability studies.
• Quality Assurance (QA): Responsible for review and approval of stability protocols, data, and reports.

4. Accountability

The Head – Quality Assurance is accountable for ensuring compliance with regulatory requirements and final approval of stability study reports.

5. Procedure

5.1 Preparation and Approval of Stability Protocol

1. Prepare a Stability Protocol including:
   • Product name and batch number
   • Storage conditions as per ICH guidelines
   • Time points (e.g., 0, 3, 6, 9, 12, 18, 24, 36 months)
   • Parameters to be tested: assay, pH, viscosity, microbial limits, appearance, etc.
2. Get protocol approved by QA prior to initiation.

5.2 Sample Collection

1. Collect representative samples from a batch as per stability sampling plan.
2. Label samples with stability ID, time points, batch details, and conditions.
3. Record details in Stability Sample Logbook (Annexure-1).

5.3 Storage Conditions

1. Store samples in qualified stability chambers under the following long-term conditions:
   • 25°C ± 2°C / 60% RH ± 5% RH
   • 30°C ± 2°C / 65% RH ± 5% RH (as applicable)
2. Monitor chamber performance using calibrated data loggers.

5.4 Stability Testing

1. Conduct analytical testing at specified time intervals per protocol.
2. Use validated analytical methods for each parameter.
3. Enter results in the Stability Study Test Sheet (Annexure-2).
4. Review trends and compare against specifications.

5.5 Data Compilation and Review

1. QC to compile raw data, chromatograms, and observations.
2. QA to review and verify all stability test results.

5.6 Reporting and Archiving

1. Prepare interim and final stability study reports using Stability Report Template (Annexure-3).
2. Include graphs, statistical trend analysis, and justifications.
3. Submit reports to QA for final approval and archival.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• RH: Relative Humidity
• ICH: International Council for Harmonisation

7. Documents

1. Stability Protocol – Annexure-1
2. Stability Study Test Sheet – Annexure-2
3. Stability Study Report – Annexure-3

8. References

• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
• ICH Q1E – Evaluation for Stability Data
• Schedule M – GMP Guidelines for Pharmaceuticals

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: Stability Sample Logbook

Date	Batch No.	Sample Code	Storage Condition	Time Points	Initials

Annexure-2: Stability Study Test Sheet

Time Point	Appearance	Assay	pH	Viscosity	Microbial	Remarks
0 Month
3 Month

Annexure-3: Stability Study Report Template

Product: ___________
Batch No.: ___________
Storage Conditions: ___________
Test Parameters: Appearance, Assay, pH, Viscosity, Microbial Load
Summary:
(Provide statistical interpretation, graphs, and conclusions.)

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial SOP issued	New document	QA Head
02/06/2025	2.0	Annexures expanded, layout revised	Periodic revision	QA Head