Accuracy Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting accuracy testing during the analytical method development process, ensuring the closeness of test results to the true value of the analyte.

2) Scope

This SOP applies to all personnel involved in accuracy 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 accuracy 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. Preparation of Standard Samples:
   1. Prepare a series of standard samples containing known concentrations of the analyte.
   2. Ensure accurate preparation and labeling of standard samples.
3. Execution of Accuracy Testing:
   1. Analyze the prepared standard samples using the selected analytical method.
   2. Compare the obtained results with the true values of the standard samples.
4. Data Analysis and Reporting:
   1. Analyze accuracy testing data to assess the accuracy of the method and calculate recovery values.
   2. Document accuracy testing results and conclusions in an accuracy testing report.
5. Review and Approval:
   1. Review the accuracy testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the accuracy testing report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Accuracy Testing Report
• Standard Sample Preparation 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 Analytical Procedures
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0