Procedure for Photostability Testing of Ointments

Department	Quality Control (QC)/Quality Assurance (QA)/Research & Development (R&D)
SOP No.	SOP/Ointment/104
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 conducting photostability testing of ointments to assess their physical, chemical, and microbiological stability when exposed to light. This ensures that the formulation remains stable under normal and intense light exposure conditions.

2. Scope

This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) departments responsible for executing, monitoring, and documenting photostability studies.

3. Responsibilities

• QC Analyst: Conducts photostability testing at predefined intervals.
• QC Supervisor: Ensures compliance with the photostability study protocol.
• QA Officer: Reviews and approves photostability test results.
• R&D Scientist: Interprets data trends and suggests formulation improvements if required.
• QA Manager: Approves photostability study protocols and ensures regulatory adherence.

4. Accountability

The QA and QC Managers are accountable for ensuring compliance with ICH Q1B guidelines for photostability testing.

5. Procedure

5.1 Preparation for Photostability Testing

• Ensure the photostability study protocol is approved before initiation.
• Select representative ointment batches for testing.
• Label stability samples with batch number, manufacturing date, and study conditions.
• Use both protected and unprotected samples to assess the effect of light exposure.

5.2 Light Exposure Conditions

• Use a light chamber complying with ICH Q1B standards.
• Ensure total exposure to a minimum of:
  • 1.2 million lux hours for visible light.
  • 200 watt-hours/m² for near-ultraviolet (UV) light.
• Control temperature within 25°C ± 2°C and relative humidity at 60% ± 5% RH.

5.3 Stability Testing Parameters

• Physical Properties: Observe changes in color, texture, phase separation, or liquefaction.
• Chemical Stability: Analyze the active ingredient content and degradation products.
• Microbiological Testing: Perform microbial limit tests to detect contamination.
• pH Measurement: Determine the impact of light exposure on pH values.
• Viscosity Analysis: Evaluate changes in consistency and spreadability.

5.4 Sampling Intervals

• Collect stability samples at predefined intervals: 0, 3, 6, 9, and 12 months.
• Perform all tests as per the photostability study protocol.
• Document all test results in the Stability Testing Log.

5.5 Handling Out-of-Specification (OOS) Results

• Identify any deviations from the acceptance criteria.
• Initiate an Out-of-Specification (OOS) investigation if required.
• Implement corrective and preventive actions (CAPA) if necessary.

5.6 Documentation and Data Analysis

• Record all test results in the Photostability Study Report.
• Ensure data integrity and traceability.
• QA must approve photostability data before finalizing the report.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• ICH – International Council for Harmonisation
• RH – Relative Humidity
• OOS – Out-of-Specification

7. Documents

• Stability Testing Log (Annexure-1)
• Photostability Study Report (Annexure-2)

8. References

• ICH Q1B Stability Testing: Photostability 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 Testing Log

Date	Batch Number	Storage Condition	Testing Interval	Parameter Tested	Result	Reviewed By
01/02/2025	OINT-401	1.2M lux hrs	6 Months	Color Stability	Compliant	QA Officer
01/08/2025	OINT-401	1.2M lux hrs	12 Months	Assay	Stable	QA Officer

Annexure-2: Photostability Study Report

Batch Number	Study Start Date	Study End Date	Test Parameters	Results	Final Conclusion
OINT-401	01/02/2025	01/02/2026	pH, Viscosity, Microbial Limits	Compliant	Meets Stability Criteria
OINT-402	01/03/2025	01/03/2026	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