Method Validation Execution in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for executing the method validation study during the analytical method development process, ensuring that the validation protocol is followed meticulously.

2) Scope

This SOP applies to all personnel involved in method validation execution 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 validation execution.

4) Procedure

1. Protocol Review:
   1. Review the approved method validation protocol to understand study objectives, validation parameters, and acceptance criteria.
   2. Ensure all required materials, instruments, and reagents are available and calibrated.
2. Sample Preparation:
   1. Prepare validation samples according to the protocol requirements.
   2. Include appropriate controls and replicate samples as specified.
3. Method Execution:
   1. Perform method validation experiments as per the validated protocol.
   2. Record all experimental data accurately and ensure traceability of samples.
4. Data Analysis:
   1. Analyze validation data using predefined statistical methods and acceptance criteria.
   2. Document data analysis results and conclusions.
5. Report Preparation:
   1. Prepare a comprehensive validation report summarizing the study objectives, methods, results, and conclusions.
   2. Include all necessary documentation, raw data, and statistical analyses in the report.
6. Review and Approval:
   1. Review the validation report for accuracy, completeness, and compliance with regulatory requirements.
   2. Obtain necessary approvals from stakeholders before finalizing and distributing the validation report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Validation Report
• Validation Raw Data
• Data Analysis Records
• Approval Records
• Distribution Records

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