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
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