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, and compliance with protocol requirements.
   2. Obtain necessary approvals from sending and receiving laboratories/sites before initiating method transfer.
6. Documentation:
   1. Document the method transfer protocol preparation process, including protocol objectives, transfer plan, data compilation, protocol drafting, review, and approval.
   2. Maintain records of all method transfer protocol activities, communications, and approvals.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Transfer Protocol Document
• Validation Data and Documents
• 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