Procedure for Documentation of Stability Study Results

Department	Quality Control (QC)/Quality Assurance (QA)/Research & Development (R&D)
SOP No.	SOP/Ointment/107
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for documenting stability study results for ointments. This ensures that stability data is recorded systematically, analyzed accurately, and maintained for regulatory compliance.

2. Scope

This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) departments responsible for recording, reviewing, and maintaining stability study results.

3. Responsibilities

• QC Analyst: Records stability test results at defined intervals.
• QC Supervisor: Reviews data accuracy and ensures compliance with study protocols.
• QA Officer: Verifies the completeness and correctness of stability documentation.
• R&D Scientist: Analyzes data trends and provides recommendations if necessary.
• QA Manager: Approves final documentation and ensures compliance with regulatory guidelines.

4. Accountability

The QA and QC Managers are accountable for ensuring stability study documentation aligns with ICH Q1A(R2) guidelines.

5. Procedure

5.1 Data Recording Requirements

• Ensure that all stability study results are documented in a pre-approved format.
• Each data entry must include:
  • Batch number
  • Storage condition
  • Testing interval
  • Parameter tested
  • Result obtained
  • Name and signature of the analyst

5.2 Stability Data Analysis

• Analyze stability data for trends and significant variations.
• Compare results against predefined acceptance criteria.
• Document any deviations and initiate Out-of-Specification (OOS) procedures if necessary.

5.3 Review and Approval Process

• QC Supervisor reviews raw data for accuracy and completeness.
• QA Officer verifies results and ensures data integrity.
• Final approval of the stability study report by the QA Manager.

5.4 Handling Deviations and Out-of-Specification (OOS) Results

• Document deviations and OOS findings in the Stability Deviation Log.
• Investigate and identify the root cause of any stability failures.
• Implement corrective and preventive actions (CAPA) if necessary.

5.5 Storage and Retention of Stability Study Data

• Store stability records in a secure, controlled-access location.
• Ensure compliance with regulatory record retention policies (e.g., minimum 5 years after product expiry).
• Maintain electronic backups for long-term storage.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• ICH – International Council for Harmonisation
• OOS – Out-of-Specification
• CAPA – Corrective and Preventive Action

7. Documents

• Stability Study Result 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

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 Result Log

Date	Batch Number	Storage Condition	Testing Interval	Parameter Tested	Result	Reviewed By
01/02/2025	OINT-701	25°C/60% RH	6 Months	Viscosity	Compliant	QA Officer
01/08/2025	OINT-701	25°C/60% RH	12 Months	pH	Stable	QA Officer

Annexure-2: Final Stability Study Report

Batch Number	Study Start Date	Study End Date	Test Parameters	Results	Final Conclusion
OINT-701	01/02/2025	01/02/2028	pH, Viscosity, Microbial Limits	Compliant	Meets Stability Criteria
OINT-702	01/03/2025	01/03/2028	Appearance, Assay, Microbial Limits	Compliant	Meets Stability Criteria

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