Method Validation Report Preparation in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for preparing the method validation report during the analytical method development process, documenting the results and conclusions of the validation study.

2) Scope

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

4) Procedure

1. Validation Data Compilation:
   1. Collect and compile all validation data, including raw data, experimental observations, and data analyses.
   2. Ensure traceability and completeness of data collected.
2. Report Structure:
   1. Structure the validation report according to predefined sections, including introduction, methods, results, discussion, and conclusions.
   2. Include all required documentation, such as validation protocols, sample preparation records, and method validation data.
3. Data Analysis and Interpretation:
   1. Analyze validation results to determine method performance against predefined acceptance criteria.
   2. Interpret data and provide scientific rationale for validation conclusions.
4. Approval and Finalization:
   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 report preparation in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Validation Report
• Validation Protocols
• 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