Method Suitability Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting method suitability testing during the analytical method development process, ensuring that the selected analytical method is suitable for its intended purpose.

2) Scope

This SOP applies to all personnel involved in method suitability 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 method suitability testing.

4) Procedure

1. Selection of Analytical Method:
   1. Select appropriate analytical method based on method requirements and regulatory guidelines.
   2. Verify method suitability for intended use and sample matrix.
2. Sample Preparation:
   1. Prepare samples according to method requirements, ensuring proper handling and storage.
   2. Include control samples to assess method performance.
3. Method Execution:
   1. Perform analysis using the selected analytical method.
   2. Ensure method parameters are optimized for accuracy, precision, and sensitivity.
4. Data Analysis and Reporting:
   1. Analyze method suitability testing data to assess method performance.
   2. Document method suitability testing results and conclusions in a testing report.
5. Review and Approval:
   1. Review the testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the testing report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Suitability Testing Report
• Sample Preparation Records
• Data Analysis and Results Documentation
• Review and Approval Records
• Method Development Plan

7) Reference, if any

Regulatory guidelines related to this SOP include:

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

8) SOP Version

Version 1.0