Preparing Method Transfer Report for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for preparing the method transfer report during the analytical method development process, summarizing the successful transfer of validated methods between laboratories or sites.

2) Scope

This SOP applies to all personnel involved in preparing method transfer reports 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 preparing method transfer reports.

4) Procedure

1. Review of Method Transfer:
   1. Review the completed method transfer execution activities and validation results.
   2. Ensure all necessary documentation and records from sending and receiving laboratories/sites are available.
2. Compilation of Transfer Details:
   1. Compile detailed information on the method transfer process, including timelines, activities, and validation outcomes.
   2. Document any deviations encountered during method transfer and their resolutions.
3. Preparation of Transfer Report:
   1. Draft the method transfer report document, ensuring clarity and completeness of information.
   2. Include sections on method transfer objectives, execution details, validation results, and conclusions.
4. Review and Approval:
   1. Review the draft method transfer report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the method transfer report.
5. Documentation:
   1. Document the method transfer report preparation process, including review of method transfer, compilation of details, report preparation, review, and approval.
   2. Maintain records of all method transfer report activities, communications, and approvals.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to method transfer report preparation for analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Transfer Execution Report
• Validation Results Documentation
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q2(R1): Validation of Analytical Procedures
• USP General Chapter Transfer of Analytical Procedures

8) SOP Version

Version 1.0