and Quality Control departments.

3. Responsibilities

• QC Analyst: Collects and compiles raw data from stability studies.
• Stability Coordinator: Reviews and organizes data, performs trend analysis, and prepares reports.
• QA Officer: Verifies data integrity, approves reports, and ensures compliance with guidelines.

4. Accountability

The Head – Quality Assurance is accountable for ensuring the stability data analysis is conducted accurately and documented as per regulatory requirements.

5. Procedure

5.1 Data Compilation

1. Collect all raw data points from physical, chemical, microbiological, and functional tests conducted at each time point (e.g., 0, 1, 3, 6, 9, 12, 18, 24 months).
2. Ensure the data is compiled in the Stability Data Compilation Template (Annexure-1).

5.2 Data Validation

1. Check for missing entries, data duplication, transcription errors, or unit inconsistencies.
2. Ensure outliers are investigated and supported with deviation records if retained.

5.3 Statistical Analysis

1. Conduct trend analysis using graphical tools such as line charts, control charts, and regression curves.
2. Calculate slope, confidence intervals, and mean degradation rate for assay and other key attributes.
3. Determine shelf-life based on significant change or degradation threshold as per ICH guidelines.

5.4 Evaluation Criteria

1. Compare all test parameters (assay, pH, viscosity, microbial count, appearance) against specification limits.
2. Evaluate if any critical quality attribute falls outside acceptable range over time.
3. Assess if accelerated condition data supports extrapolation of long-term stability claims.

5.5 Report Preparation

1. Summarize findings in the Stability Analysis Report Template (Annexure-2).
2. Include interpretation, graphical representation, and statistical tables in the report.
3. Attach signed data sets and cross-reference sample IDs and time points.

5.6 Review and Approval

1. QA will review the analysis report and verify all conclusions and calculations.
2. Discrepancies or observations will be communicated for clarification or revision.
3. Upon final approval, the report will be archived and referenced for regulatory submissions.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• ICH: International Council for Harmonisation
• RSD: Relative Standard Deviation

7. Documents

1. Stability Data Compilation Template – Annexure-1
2. Stability Analysis Report Template – Annexure-2
3. Trend Analysis Summary Sheet – Annexure-3

8. References

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

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

Annexure-2: Stability Analysis Report Template

Section	Details
Batch Number
Storage Condition
Study Duration
Statistical Summary
Graphs Attached	Yes/No
Deviation Remarks
Conclusion

Annexure-3: Trend Analysis Summary Sheet

Parameter	Trend Observed	Compliance	Remarks
Assay		Yes/No
pH		Yes/No
Viscosity		Yes/No
Microbial Load		Yes/No

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial SOP implementation	New Product Launch	QA Head
02/06/2025	2.0	Added statistical tools and revised annexures	Compliance Update	QA Head