Manufacturing and Quality Control departments.

3. Responsibilities

• Stability Coordinator: Compiles, verifies, and manages stability data.
• QC Analyst: Performs stability testing as per the approved protocol and records data.
• QA Officer: Reviews stability data for compliance with specifications and regulatory filing.

4. Accountability

The Head – Quality Assurance is accountable for the final approval of stability data analysis reports and ensuring adherence to regulatory requirements.

5. Procedure

5.1 Data Compilation

1. Stability test data (physical, chemical, and microbiological) should be recorded at each time point (0, 1, 3, 6, 9, 12, 18, and 24 months for long-term; 0, 1, 2, 3, and 6 months for accelerated).
2. Data shall be captured in a tabular format using the “Stability Data Compilation Sheet” (Annexure-1).
3. Ensure all data is transcribed directly from raw data sheets or instrument printouts without alteration.

5.2 Data Validation

1. Check for any transcription errors, missing entries, unit inconsistencies, or deviations from specifications.
2. Investigate any out-of-trend (OOT) or out-of-specification (OOS) results through QA deviation handling procedures.

5.3 Trend Analysis

1. Plot stability-indicating parameters such as assay, pH, viscosity, microbial load, and appearance over time.
2. Use statistical tools such as regression analysis or ANOVA to identify trends and predict shelf-life degradation patterns.
3. Interpret the data to assess whether there is any significant change in quality attributes over time.

5.4 Shelf-Life Determination

1. Use ICH Q1E guidelines to apply statistical approaches for estimating shelf-life.
2. If no significant changes are observed during the stability period, use the last compliant time point as a reference for assigning shelf life.
3. Document the rationale for shelf-life determination in the final report.

5.5 Report Generation

1. Compile findings into a “Stability Data Analysis Report” (Annexure-2), which should include summary tables, trend charts, interpretations, and conclusions.
2. The report should be signed by the Stability Coordinator, reviewed by QC Manager, and approved by QA Head.

5.6 Regulatory Compliance

1. Ensure that data presentation aligns with regulatory submission formats (e.g., CTD format).
2. Store all analytical data and summary reports in the stability archive system for future inspection and audit readiness.

6. Abbreviations

• OOT: Out-of-Trend
• OOS: Out-of-Specification
• CTD: Common Technical Document
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure

7. Documents

1. Stability Data Compilation Sheet – Annexure-1
2. Stability Data Analysis Report – Annexure-2
3. Stability Protocol
4. Stability Summary for Regulatory Submission

8. References

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

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 Data Compilation Sheet

Time Point	Assay (%)	pH	Viscosity (cP)	Appearance	Microbial Count (cfu/g)	Remarks
0 Month
1 Month
3 Month

Annexure-2: Stability Data Analysis Report

Batch No.
Product Name
Storage Condition
Study Type	(Accelerated / Real-time)
Shelf-life Conclusion
Summary of Findings
Prepared By
Reviewed By
Approved By

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial release	New SOP	QA Head
02/06/2025	2.0	Included updated ICH references and annexures	Annual Review	QA Head