Preparing Method Transfer Protocol for Analytical Method Development

1) Purpose

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

2) Scope

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

4) Procedure

1. Protocol Objectives:
   1. Define the objectives and scope of the method transfer protocol.
   2. Identify the sending and receiving laboratories/sites involved in method transfer.
2. Method Transfer Plan:
   1. Develop a detailed plan for transferring the validated analytical method(s) from the sending to the receiving laboratory/site.
   2. Specify the roles, responsibilities, and timelines for each laboratory/site during method transfer.
3. Validation Data Compilation:
   1. Compile relevant validation data and documents from the sending laboratory/site.
   2. Ensure completeness and accuracy of validation data to support method transfer.
4. Transfer Protocol Preparation:
   1. Draft the method transfer protocol document, including sections on methodology, acceptance criteria, and responsibilities.
   2. Review the protocol draft with stakeholders to incorporate feedback and ensure clarity and compliance.
5. Review and Approval:
   1. Review the final method transfer protocol document for accuracy, completeness,