System Suitability Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting system suitability testing (SST) during the analytical method development process, ensuring the reliability and reproducibility of analytical systems and methods.

2) Scope

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

4) Procedure

1. Selection of Analytical System:
   1. Select appropriate analytical system (e.g., chromatographic system, spectroscopic system) based on method requirements.
   2. Verify the operational status and suitability of the analytical system for intended use.
2. System Suitability Parameters:
   1. Define system suitability parameters including resolution, tailing factor, retention time, and peak area.
   2. Establish acceptance criteria based on method validation requirements and regulatory guidelines.
3. Execution of System Suitability Testing:
   1. Perform system suitability tests using standard reference materials or test solutions.
   2. Record system suitability test results and ensure data integrity and traceability.
4. Data Analysis and Reporting:
   1. Analyze system suitability test data to assess analytical system performance.
   2. Document system suitability testing results and conclusions in a system suitability test report.
5. Review and Approval:
   1. Review the system suitability test report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the system suitability test report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• System Suitability Test Report
• Reference Material or Test Solution Documentation
• 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 System Suitability
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0