Manufacturing department that require accelerated stability studies prior to commercial release or regulatory submissions.

3. Responsibilities

• Quality Control (QC): Responsible for conducting the stability tests and maintaining documentation.
• Stability Coordinator: Ensures timely execution, monitoring, and documentation of the study.
• Quality Assurance (QA): Responsible for review and approval of study protocols and results.

4. Accountability

The Head – Quality Assurance is accountable for ensuring adherence to regulatory standards and maintaining data integrity of stability testing.

5. Procedure

5.1 Preparation of Stability Protocol

1. Draft the stability study protocol that includes:
   • Product name, batch number, and storage conditions
   • Testing intervals (0, 1, 2, 3, and 6 months)
   • Test parameters: assay, pH, viscosity, microbial load, appearance, and others
2. Get the protocol approved by QA prior to study initiation.

5.2 Sample Collection and Labeling

1. Collect adequate number of final product containers from each batch.
2. Label each sample with stability ID, batch number, storage condition, and time points.
3. Record the details in the Accelerated Stability Sample Logbook (Annexure-1).

5.3 Storage Conditions

1. Store samples in stability chambers at:
   • 40°C ± 2°C / 75% RH ± 5% RH (ICH recommended)
2. Chambers must be qualified and monitored using data loggers.

5.4 Stability Testing Schedule

1. Perform tests at defined intervals (0, 1, 2, 3, and 6 months).
2. Ensure that all analytical methods are validated for accuracy and precision.
3. Record all results in the Accelerated Stability Data Sheet (Annexure-2).

5.5 Data Analysis and Reporting

1. QC compiles raw data, chromatograms, and observations.
2. QA verifies the integrity and accuracy of the results.
3. Use trend charts and statistical tools to assess degradation or anomalies.

5.6 Final Report

1. Prepare a final report using the template (Annexure-3).
2. Include conclusions, graphical analysis, and justification for product shelf life.
3. Submit the report to QA for final approval.

6. Abbreviations

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

7. Documents

1. Accelerated Stability Protocol – Annexure-1
2. Accelerated Stability Data Sheet – Annexure-2
3. Accelerated Stability Final Report – Annexure-3

8. References

• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
• WHO Stability Guidelines
• 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: Accelerated Stability Sample Logbook

Date	Batch No.	Sample Code	Storage Condition	Time Points	Initials
			40°C/75%RH	0,1,2,3,6 months

Annexure-2: Accelerated Stability Data Sheet

Time Point	Appearance	Assay	pH	Viscosity	Microbial Load	Remarks
0 Month
1 Month

Annexure-3: Accelerated Stability Final Report Template

Product Name: ___________
Batch No.: ___________
Storage Condition: 40°C ± 2°C / 75% RH ± 5% RH
Duration: 6 Months
Summary: Include graphical plots, test results, out-of-spec data, conclusions on stability.

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial SOP release	New document	QA Head
02/06/2025	2.0	Updated annexures, improved reporting structure	Annual review	QA Head