Robustness Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting robustness testing during the analytical method development process, ensuring the reliability and robust performance of analytical methods under varying conditions.

2) Scope

This SOP applies to all personnel involved in robustness testing for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in robustness testing.

4) Procedure

1. Selection of Analytical Method:
   1. Select appropriate analytical method based on method requirements and regulatory guidelines.
   2. Verify method suitability and performance characteristics.
2. Identification of Robustness Parameters:
   1. Identify critical method parameters (e.g., pH, temperature, mobile phase composition) for robustness evaluation.
   2. Define variations or tolerances for each parameter based on method validation requirements.
3. Execution of Robustness Testing:
   1. Perform robustness testing by deliberately varying identified parameters within defined limits.
   2. Conduct multiple experiments or replicate tests to assess method performance under different conditions.
4. Data Analysis and Reporting:
   1. Analyze robustness testing data to evaluate method robustness and identify critical parameters affecting method performance.
   2. Document robustness testing results and conclusions in a robustness testing report.
5. Review and Approval:
   1. Review the robustness testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the robustness testing report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to robustness testing in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Robustness Testing Report
• Method Validation Records
• Data Analysis and Results Documentation
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• USP General Chapter Validation of Compendial Procedures
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0