Executing Method Validation for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for executing method validation during the analytical method development process, ensuring that the developed method meets predefined acceptance criteria and regulatory requirements.

2) Scope

This SOP applies to all personnel involved in executing method validation 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 executing method validation for analytical method development.

4) Procedure

1. Protocol Review:
   1. Review the approved method validation protocol to understand objectives, acceptance criteria, and experimental design.
   2. Ensure that all necessary resources and materials are available for validation execution.
2. Preparation of Validation Samples:
   1. Prepare validation samples according to the defined protocol and acceptance criteria.
   2. Document sample preparation procedures and ensure traceability of sample identity.
3. Execution of Validation Experiments:
   1. Perform validation experiments under controlled conditions as per the validated protocol.
   2. Record all experimental parameters, observations, and data accurately.
4. Data Analysis:
   1. Analyze validation data using appropriate statistical methods and compare results against predefined acceptance criteria.
   2. Document data analysis procedures and ensure accuracy of results interpretation.
5. Validation Report Preparation:
   1. Compile validation data and prepare a comprehensive validation report summarizing experimental details, results, conclusions, and recommendations.
   2. Include sections on data analysis, deviations, and corrective actions taken during validation.
6. Review and Approval:
   1. Review the validation report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the validation report.
7. Documentation:
   1. Document the method validation execution process, including protocol review, sample preparation, validation experiments, data analysis, report preparation, review, and approval.
   2. Maintain records of all validation execution activities, communications, and approvals.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Validation Protocol
• Validation Samples Documentation
• Validation Experimental Records
• Validation Report
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q2(R1): Validation of Analytical Procedures
• FDA Guidance for Industry: Analytical Procedures and Methods Validation

8) SOP Version

Version 1.0