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SOP for Conducting Photostability Testing of Drug Products

Procedure for Photostability Testing of Drug Products

1) Purpose

The purpose of this SOP is to provide a detailed procedure for conducting photostability testing of drug products to evaluate their stability when exposed to light, in order to determine suitable packaging and storage conditions.

2) Scope

This SOP applies to all drug products that require photostability testing to determine their shelf life and appropriate packaging requirements. It is relevant for personnel in quality control, research and development, and regulatory affairs departments.

3) Responsibilities

The responsibilities for conducting photostability testing of drug products are as follows:

Quality Control Team:

To perform the photostability tests as per the protocol and document results.

R&D Team: To design the photostability study protocol and provide technical support.

Regulatory Affairs Team: To ensure compliance with regulatory guidelines during photostability testing.

Stability Study Coordinator: To manage testing schedules, sample management, and data analysis.

4) Procedure

The detailed stepwise procedure for conducting photostability testing of drug products is outlined below:

Preparation of Photostability Study Protocol:

4.1 Define the purpose, scope, and objective of the photostability testing.
4.2 Identify the drug product and the critical quality attributes (CQAs) to be monitored.
4.3 Determine the light exposure conditions to be tested (e.g., exposure to UV and visible light).
4.4 Establish the time points for testing under each light exposure condition.
4.5 Develop a protocol outlining procedures, equipment, and materials required for testing.

Sample Preparation and Storage:

4.6 Select representative samples of the drug product for testing.
4.7 Prepare and package samples in transparent containers to simulate light exposure conditions.
4.8 Expose samples to specified light conditions in a photostability chamber.

Testing and Monitoring:

4.9 Retrieve samples at specified time points and perform the required tests (e.g., assay, degradation products, dissolution).
4.10 Record all test results in a photostability testing log sheet.
4.11 Evaluate the results against predefined acceptance criteria.

Data Analysis and Interpretation:

4.12 Analyze the photostability data to identify any trends or deviations due to light exposure.
4.13 Determine the impact of light on the stability of the drug product.
4.14 Document any significant findings or trends in the data.

Documentation and Reporting:

4.15 Compile a comprehensive photostability study report including objectives, methods, results, and conclusions.
4.16 Ensure the report is reviewed and approved by relevant stakeholders.
4.17 Submit the report to regulatory bodies or internal stakeholders as required.

Review and Update:

4.18 Regularly review the photostability testing protocol and update it based on new data or regulatory changes.
4.19 Archive the approved protocol and report in a controlled document management system.

5) Abbreviations, if any

CQA: Critical Quality Attribute
UV: Ultraviolet

6) Documents, if any

Photostability Study Protocol
Photostability Testing Log Sheets
Photostability Study Report Template

7) Reference, if any

ICH Q1B: Photostability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0