Procedure for Light Exposure Testing
1) Purpose
The purpose of this SOP is to outline the procedure for conducting light exposure testing on pharmaceutical products to assess the potential impact of light exposure on product stability and quality.
2) Scope
This SOP applies to all pharmaceutical products susceptible to degradation due to light exposure, requiring periodic testing to ensure compliance with regulatory requirements and internal specifications.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing light exposure testing.
Facility Engineering: Responsible for providing appropriate testing facilities and maintaining light exposure conditions.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
4) Procedure
4.1 Study Planning:
4.1.1 Identify pharmaceutical products requiring light exposure testing based on stability study data and regulatory guidelines.
4.1.2 Determine exposure conditions (e.g., light intensity, exposure duration) based on product-specific requirements.
4.2 Sample Preparation:
4.2.1 Select representative samples of pharmaceutical products for testing.
4.2.2 Document product information, including batch number, expiry date, and storage conditions prior to testing.
4.3 Exposure Testing:
4.3.1 Expose samples to controlled light conditions as per defined exposure parameters.
4.3.2 Monitor environmental conditions (e.g., temperature, humidity) during the exposure period.
4.3.3 Protect samples from direct contact with light sources that could alter exposure conditions.
4.4 Sample Analysis:
4.4.1 Retrieve samples after the designated exposure period.
4.4.2 Perform analytical testing (e.g., assay, degradation products analysis) to assess changes in product quality due to light exposure.
4.4.3 Compare test results against acceptance criteria and historical data to determine product stability under light exposure.
4.5 Reporting:
4.5.1 Prepare a Light Exposure Testing Report summarizing test objectives, methodology, results, and conclusions.
4.5.2 Include recommendations for product handling or packaging improvements if applicable.
4.5.3 Submit the report to QA for review and approval and archive records as per facility procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Light Exposure Testing Report
Product Stability Study Data
7) Reference, if any
ICH Q1B – Photostability Testing of New Drug Substances and Products
FDA Guidance for Industry – Q1 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
8) SOP Version
Version 1.0
