Standard Operating Procedure for Conducting Photostability Testing Following ICH Q1B
1) Purpose
The purpose of this SOP is to provide guidance on conducting and interpreting photostability testing in accordance with ICH Q1B guidelines to ensure that drug substances and products are not adversely affected by exposure to light.
2) Scope
This SOP applies to all drug substances and products requiring photostability testing as per ICH Q1B guidelines. It is relevant to departments involved in quality control, quality assurance, regulatory affairs, and production.
3) Responsibilities
- Quality Control (QC) Team: Conducts photostability testing using validated methods.
- Quality Assurance (QA) Team: Reviews test
protocols and final reports to ensure compliance with ICH Q1B guidelines.
Regulatory Affairs Team: Prepares data for submission according to regulatory requirements.
4) Procedure
- Development of Photostability Protocol
- Prepare a protocol that includes light exposure conditions, test intervals, and analytical methods for photostability testing.
- Submit the protocol for review and approval to the QA team.
- Execution of Photostability Testing
- Expose samples to specified light sources as per ICH Q1B guidelines.
- Conduct tests at designated intervals to assess any physical or chemical changes due to light exposure.
- Document all test results, observations, and deviations from the protocol.
- Data Analysis and Reporting
- Analyze test data to determine the impact of light exposure on the drug product’s stability.
- Prepare a photostability report and submit it to the QA team for review.
5) Abbreviations, if any
- QC: Quality Control
- QA: Quality Assurance
- ICH: International Council for Harmonisation
6) Documents, if any
- Photostability Test Protocol
- Photostability Test Reports
7) Reference, if any
- ICH Q1B: Photostability Testing of New Drug Substances and Products
8) SOP Version
Version 1.0