Method Validation Protocol Preparation in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for preparing the method validation protocol during the analytical method development process, ensuring that the validation study is planned and documented effectively.

2) Scope

This SOP applies to all personnel involved in method validation protocol preparation 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 protocol preparation.

4) Procedure

1. Protocol Outline:
   1. Define the scope and objectives of the method validation study.
   2. Outline the experimental design, including validation parameters and acceptance criteria.
2. Method Description:
   1. Provide a detailed description of the analytical method to be validated.
   2. Include information on method principle, procedure, and critical method parameters.
3. Validation Parameters:
   1. Specify validation parameters such as specificity, accuracy, precision, linearity, range, and robustness.
   2. Define acceptance criteria for each validation parameter based on regulatory guidelines and method requirements.
4. Experimental Plan:
   1. Develop a detailed experimental plan, including sample preparation, analytical procedure, and data analysis.
   2. Document statistical methods and calculations to be used for data analysis.
5. Approval and Distribution:
   1. Review the method validation protocol for accuracy, completeness, and compliance with regulatory requirements.
   2. Obtain necessary approvals from stakeholders and distribute the approved protocol to all relevant personnel.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Validation Protocol
• Validation Plan
• Approval Records
• Distribution Records
• Method Development Reports

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