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Process of Analytical Method Transfer

Process of Analytical Method Transfer

This  eLearning  module covers the guideline for analytical method transfer applicable to all analytical methods used for the analysis of In-process, Intermediate and Finished Product.​


  • Document sharing by the receiving laboratory to provide information on the equipment required and procedures.​

  • Types of transfer including one-sided, two-sided, and co-qualification type of method transfer​

  • Qualification for a transfer waiver​

  • Preparation and approval of a detailed method transfer protocol detailing roles of both laboratories, instruction on the process, and acceptance criteria that needs to be fulfilled for a successful transfer​

  • Transportation of samples to the receiving laboratory​

  • Training and method familiarization activity for analysts​

  • Conducting the transfer and evaluating the parameters as per the predefined acceptance criteria​

  • Investigation of any incidents and deviations​

  • Method transfer report and its approval​

  • Auditor Interactions​

  • Graded assessment​

  • Why it matters

    Understanding the steps involved in conducting a successful analytical method transfer between transferring and receiving laboratories, the responsibilities of various personnel, and the step by step execution of a method transfer activity according to the transfer protocol is important in QC biologics.​

  • Who is it for​ ​

    This module is designed for all employees in analytical​

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