this facility, including new product development, validation batches, and post-approval changes requiring submission to regulatory authorities.

3. Responsibilities

• Stability Coordinator: Compiles study data and drafts the initial report.
• QC Analyst: Provides raw data and analytical results.
• QA Executive: Reviews data integrity, accuracy, and compliance before submission.
• Regulatory Affairs: Finalizes the report format and aligns content with regulatory guidelines.

4. Accountability

Manager – Quality Assurance is accountable for ensuring that all stability study reports are accurate, complete, and submitted within regulatory timelines.

5. Procedure

5.1 Collection of Data

1. Obtain approved stability protocol and ensure tests are performed per the schedule outlined in ICH Q1A(R2) guidelines.
2. Collect data for all prescribed storage conditions (e.g., 25°C/60%RH, 30°C/65%RH, 40°C/75%RH).
3. Compile test parameters including appearance, pH, assay, degradation products, viscosity, microbial limits, and preservative efficacy.

5.2 Report Structure

The report shall be structured as follows:

1. Cover Page: Title, product name, batch number, study type, study period.
2. Table of Contents
3. Executive Summary: Objectives and conclusions of the study.
4. Introduction: Background and rationale.
5. Methodology: Storage conditions, sampling intervals, test methods.
6. Results: Tabulated and graphical presentation.
7. Discussion: Data interpretation, trends, and compliance.
8. Conclusion: Shelf-life proposal and regulatory impact.
9. Appendices: Raw data, chromatograms, certificates of analysis (COAs).

5.3 Data Presentation

1. Present results in a tabular format with time points, means, standard deviations, and specification limits.
2. Include graphical trend charts to highlight assay stability, impurity growth, and viscosity shifts.
3. Use color-coded formats for highlighting OOS/OOT results, if any.

5.4 Review and Approval

1. Initial draft reviewed by QC Lead and QA Executive for accuracy and completeness.
2. Regulatory Affairs ensures alignment with agency submission requirements (e.g., CTD format).
3. Final report to be signed by QA Head and submitted as part of product dossier or variation filing.

5.5 Archiving and Retention

1. Stability reports shall be stored in both hardcopy and electronic formats.
2. Electronic copies shall be uploaded to the Document Management System (DMS).
3. Retention period: Minimum of 5 years or as per regulatory requirement.

6. Abbreviations

• ICH: International Council for Harmonisation
• CTD: Common Technical Document
• COA: Certificate of Analysis
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. Stability Study Protocol
2. Stability Study Report – Annexure-1
3. Certificates of Analysis
4. Analytical Raw Data

8. References

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• ICH Q1E: Evaluation for Stability Data
• WHO TRS 1010 Annex 2: Stability Testing of Finished Products

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 Study Report Format

Product Name
Batch Number
Manufacturing Date
Study Period
Storage Conditions	25°C/60%RH, 30°C/65%RH, 40°C/75%RH
Study Type	Long-term / Accelerated
Stability Parameters Tested
Results Summary	Attach charts/tables
Conclusion
Prepared By
Reviewed By
Approved By

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
15/03/2022	1.0	Initial issue	New SOP	QA Head
02/06/2025	2.0	Updated template, included CTD requirements	Annual review	QA Head