3, 6, 9, 12, 18, 24, 36 months)

Testing parameters (pH, viscosity, assay, microbial limits, etc.)

Results obtained

Name and signature of the analyst

Use validated software or physical logbooks for data entry to prevent errors.

5.2 Data Verification and Review

• QC Supervisor must verify raw data for completeness, consistency, and accuracy.
• QA Officer cross-checks the data against predefined acceptance criteria.
• Any discrepancies or missing data must be documented and investigated.
• Data must be signed off by both QC and QA personnel before being finalized.

5.3 Data Integrity and Compliance

• Ensure adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
• Electronic data must be protected by audit trails to prevent unauthorized modifications.
• All changes or corrections must be documented with proper justification.
• Ensure compliance with FDA 21 CFR Part 11 (for electronic records) and WHO GMP requirements.

5.4 Data Storage and Retention

• All stability study data must be securely stored in designated locations.
• Hard copy records must be archived in locked storage cabinets accessible only to authorized personnel.
• Electronic data must be backed up regularly and stored in a validated system with restricted access.
• Records must be retained for at least five years after the product expiry date, as per regulatory requirements.

5.5 Handling Out-of-Trend (OOT) and Out-of-Specification (OOS) Results

• If stability data deviates from expected trends (OOT), an initial investigation must be conducted.
• If a parameter fails to meet acceptance criteria (OOS), initiate an OOS investigation.
• Identify the root cause of deviations and implement Corrective and Preventive Actions (CAPA).
• All findings and actions taken must be documented in the Stability Deviation Log.

5.6 Stability Data Reporting

• Compile stability study data into summary reports at predefined intervals.
• Include statistical analysis to identify trends and potential stability issues.
• QA Manager must review and approve the final stability study report.
• Reports must be available for regulatory inspections and product registrations.

5.7 Regulatory Compliance and Audit Readiness

• Ensure stability data is audit-ready for regulatory agencies (FDA, EMA, WHO, etc.).
• Regularly review data management practices to maintain compliance.
• Provide necessary stability documentation for regulatory filings.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• ICH – International Council for Harmonisation
• OOT – Out-of-Trend
• OOS – Out-of-Specification
• CAPA – Corrective and Preventive Action
• GDP – Good Documentation Practices
• ALCOA+ – Attributable, Legible, Contemporaneous, Original, Accurate

7. Documents

• Stability Study Data Log (Annexure-1)
• Final Stability Study Report (Annexure-2)

8. References

• ICH Q1A(R2) Stability Testing of New Drug Substances and Products
• WHO GMP Guidelines for Pharmaceutical Stability Studies
• FDA 21 CFR Part 11 – Electronic Records and Signatures

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Stability Study Data Log

Batch Number	Testing Interval	Parameter	Result	Reviewed By
OINT-1001	6 Months	pH	Stable	QA Officer
OINT-1002	12 Months	Viscosity	Within Limits	QA Officer

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head