Standard Operating Procedure for Light Exposure Testing for Transdermal Patches
1) Purpose
To establish a standardized procedure for conducting light exposure testing on transdermal patches to evaluate their stability and performance under light exposure conditions.
2) Scope
This SOP applies to the quality control (QC) and quality assurance (QA) departments responsible for light exposure testing of transdermal patches.
3) Responsibilities
3.1 QC Analysts: Perform light exposure tests according to the procedure.
3.2 QA Personnel: Review and approve test results and ensure compliance with the SOP.
3.3 Production Personnel: Provide samples and relevant documentation for testing.
3.4 Regulatory Affairs: Ensure that the light exposure testing procedure complies with regulatory requirements.
4) Procedure
4.1 Preparation:
4.1.1 Collect samples of transdermal patches from the production line as per the sampling plan.
4.1.2 Ensure all equipment used for light exposure testing is calibrated and in good working condition.
4.2 Light Exposure Testing:
4.2.1 Test Conditions:
4.2.1.1 Define the light exposure conditions, including light intensity and duration (e.g., 1.2 million lux hours for visible light and 200 watt-hours/square meter for UV light).
4.2.1.2 Program the light exposure chamber according to the defined conditions.
4.2.2 Test Execution:
4.2.2.1 Place the transdermal patch samples in the light exposure chamber.
4.2.2.2 Initiate the light exposure program and monitor the chamber to ensure it operates within the specified parameters.
4.2.2.3 Continue the light exposure for the required duration.
4.2.3 Post-Test Evaluation:
4.2.3.1 Remove the samples from the chamber after the test is complete.
4.2.3.2 Inspect the samples for any physical changes, such as discoloration, degradation, or changes in adhesive properties.
4.2.3.3 Conduct functional tests, such as drug release rate and adhesion testing, to assess the impact of light exposure on product performance.
4.3 Acceptance Criteria:
4.3.1 Define the acceptance criteria for physical and functional properties post light exposure.
4.3.2 Ensure that the transdermal patches meet the defined criteria without significant degradation.
4.4 Documentation:
4.4.1 Record all test results, including the test conditions, observations, and functional test outcomes.
4.4.2 Maintain records of equipment calibration and maintenance.
4.5 Review and Approval:
4.5.1 QA personnel review test results for compliance with acceptance criteria.
4.5.2 Approve or reject batches based on test outcomes.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Light Exposure Test Records
Calibration Records
Test Method Protocols
7) Reference, if any
ICH Q1B: Photostability Testing of New Drug Substances and Products
USP General Chapter 1079: Good Storage and Shipping Practices
8) SOP Version
Version 1.0
