Executing Method Transfer for Analytical Method Development

1) Purpose

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

2) Scope

This SOP applies to all personnel involved in executing method transfers 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 transfers.

4) Procedure

1. Preparation for Method Transfer:
   1. Review the approved method transfer protocol and ensure readiness for execution.
   2. Coordinate with sending and receiving laboratories/sites to confirm logistics and timelines.
2. Transfer of Method:
   1. Transfer validated analytical methods from the sending laboratory/site to the receiving laboratory/site.
   2. Follow the defined transfer plan and procedures outlined in the method transfer protocol.
3. Validation at Receiving Site:
   1. Execute validation activities at the receiving laboratory/site to verify method performance.
   2. Compare validation results with acceptance criteria specified in the method transfer protocol.
4. Documentation and Reporting:
   1. Document all activities related to method transfer execution, including timelines, deviations, and corrective actions.
   2. Prepare a method transfer execution report summarizing transfer activities and validation outcomes.
5. Review and Approval:
   1. Review the method transfer execution report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before concluding the method transfer process.
6. Documentation:
   1. Maintain records of all method transfer execution activities, including documentation of validation at the receiving site, communications, and approvals.
   2. Archive method transfer documentation in accordance with departmental and regulatory requirements.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Method Transfer Protocol
• Method Transfer Execution Report
• Validation Results at Receiving Site
• 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