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SOP for Conducting Stress Testing of Active Pharmaceutical Ingredients (APIs)

Procedure for Performing Stress Testing on Active Pharmaceutical Ingredients

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stress testing of Active Pharmaceutical Ingredients (APIs) to determine their stability under various stress conditions such as temperature, humidity, light, and oxidation.

2) Scope

This SOP applies to all APIs that require stress testing to identify potential degradation products and to establish their degradation pathways. It is relevant for personnel in quality control, research and development, and regulatory affairs departments.

3) Responsibilities

The responsibilities for conducting stress testing of APIs are

as follows:

Quality Control Team: To perform the stress tests as per the protocol and document the results.
R&D Team: To design the stress testing protocol and provide technical support.
Regulatory Affairs Team: To ensure compliance with regulatory guidelines during the stress
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testing process.
Stability Study Coordinator: To manage the stress testing schedule, sample management, and data analysis.

4) Procedure

The detailed stepwise procedure for conducting stress testing of APIs is outlined below:

Preparation of Stress Testing Protocol:

4.1 Define the purpose, scope, and objective of the stress testing.
4.2 Identify the API and the critical quality attributes (CQAs) to be monitored.
4.3 Determine the stress conditions to be tested (e.g., temperature, humidity, light, oxidation).
4.4 Establish the time points for testing under each stress 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 API for testing.
4.7 Prepare and store samples under specified stress conditions in stability chambers or other controlled environments.

Testing and Monitoring:

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

Data Analysis and Interpretation:

4.11 Analyze the stress testing data to identify degradation products and pathways.
4.12 Assess the impact of different stress conditions on the stability of the API.
4.13 Document any trends or deviations in the data.

Documentation and Reporting:

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

Review and Update:

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

5) Abbreviations, if any

API: Active Pharmaceutical Ingredient
CQA: Critical Quality Attribute

6) Documents, if any

Stress Testing Protocol
Stress Testing Log Sheets
Stress Testing Report Template

7) Reference, if any

ICH Q1A(R2): Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0