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 |