and accelerated stability testing.

3. Responsibilities

• QC Analyst: To perform sampling, testing, and documentation.
• QA Executive: To review stability data and trend reports.
• QC Head: To approve final reports and recommend shelf life.

4. Accountability

Head – Quality Control shall be accountable for ensuring proper execution and compliance with this SOP.

5. Procedure

5.1 Sample Selection

1. Collect samples from three initial commercial batches or exhibit batches as per protocol.
2. Ensure representative packaging (e.g., tubes, jars) for each market presentation.

5.2 Storage Conditions

Place samples in validated stability chambers at specified ICH conditions:

• Long-Term: 25°C ± 2°C / 60% RH ± 5% RH
• Accelerated: 40°C ± 2°C / 75% RH ± 5% RH
• Intermediate (if required): 30°C ± 2°C / 65% RH ± 5% RH

5.3 Time Points

Perform testing at the following intervals unless otherwise specified:

• Long-Term: 0, 3, 6, 9, 12, 18, and 24 months
• Accelerated: 0, 3, and 6 months

5.4 Stability Testing Parameters

• Appearance (color, clarity, homogeneity)
• Odor and pH
• Viscosity and Spreadability
• Assay of Active Ingredient(s)
• Preservative Content (if applicable)
• Microbial Limit Test
• Preservative Efficacy Test (selected batches)
• Container-closure integrity (where applicable)

5.5 Testing Procedure

1. Withdraw required quantity of each sample at respective intervals.
2. Perform testing as per validated analytical methods and SOPs.
3. Document all results with proper calculations and chromatograms where applicable.

5.6 Data Review and Trending

1. Compare results with initial values and specifications.
2. Identify and document any trends or deviations.
3. Initiate investigation if OOS or atypical trends are observed.

5.7 Report Preparation

1. Compile a stability report at each milestone and at study completion.
2. Include results, graphs, conclusions, and any recommendations for shelf life adjustment.

5.8 Document Retention

All raw data, printouts, and reports shall be archived in the QC documentation room for a minimum of five years or as per regulatory requirement.

6. Abbreviations

• ICH: International Council for Harmonisation
• RH: Relative Humidity
• OOS: Out of Specification
• SOP: Standard Operating Procedure

7. Documents

1. Stability Protocol Template – Annexure-1
2. Stability Summary Report Format – Annexure-2
3. Stability Sample Withdrawal Log – Annexure-3
4. Stability Data Trending Chart – Annexure-4

8. References

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• WHO Technical Report Series – Stability Studies
• Internal Method Validation SOPs

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 Protocol Template

Product Name
Batch No.
Storage Conditions
Time Points
Testing Parameters
Prepared By
Approved By

Annexure-2: Stability Summary Report Format

Time Point	Parameter	Result	Limit	Remarks
0 Month	pH
3 Months	Assay
6 Months	Viscosity

Annexure-3: Stability Sample Withdrawal Log

Date	Batch No.	Storage Condition	Time Point	Withdrawn By	Signature

Annexure-4: Stability Data Trending Chart

Parameter	Time Point	Observed Value	Trend Observed	Remarks
Assay	0M, 3M, 6M, 12M

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
08/05/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Revised per ICH update	Compliance Requirement	QA Head