Precision Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting precision testing during the analytical method development process, ensuring the repeatability and reproducibility of the method.

2) Scope

This SOP applies to all personnel involved in precision 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 precision 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 Sample Sets:
   1. Prepare multiple sample sets containing replicates of the analyte.
   2. Ensure accurate preparation and labeling of sample sets.
3. Execution of Precision Testing:
   1. Analyze each sample set using the selected analytical method.
   2. Calculate precision parameters such as repeatability and intermediate precision.
4. Data Analysis and Reporting:
   1. Analyze precision testing data to assess the precision of the method and calculate % RSD (relative standard deviation).
   2. Document precision testing results and conclusions in a precision testing report.
5. Review and Approval:
   1. Review the precision testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the precision testing report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Precision Testing Report
• Sample Set 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