Method transfer - Good to know
Method transfer, as the name suggests, is the transfer of a previously validated method to a new lab for its testing of the same samples under new conditions. Method transfer can happen between different sites of one pharmaceutical company (e.g. from the development department to the production site in different countries) or in case of a drug being sold from one company sold to another.
Why is it important?
At the time of globalization, most pharmaceutical companies are expanding and are trying to find new locations for the manufacturing of their drug substances and drug products. This way, the companies save a lot of money and improve on the logistics of their (new) products. In the time of fierce competition, quality alone is not enough. It must be supplemented with better pricing, faster development and quicker delivery.
At the following pages some details about method transfers are shown.
Procedure and requirements for method transfers
According to the title the course of a transfer is summarized. This includes the planning phase, the creation of a transfer plan and after performance of the experiments the creation of a transfer report as well.
Planning phase – Preparing a method transfer
In this article details of the planning phase are presented.
Types of transfer and transfer strategy
Here, the different transfer types (comparative transfer, covalidation, full validation or transfer waiver) which are part of the transfer strategy are explained.
This article provides an overview about all aspects to be covered by the transfer plan.
Acceptance criteria of comparative method transfers
In this article we explain how acceptance criteria are defined and what needs to be considered.