Transfer of Analytical Methods for Pharmaceutical Analysis

25 October 2012, Dublin, Ireland

Introduction

Transferring an analytical method from one laboratory to another should be straightforward but unfortunately it is a process which is often problematic. Recognition of this has resulted in a new USP chapter <1224> Transfer of Analytical Procedures, and a proposal for inclusion in an update of the EU GMP regulations. In this one day course from Mourne Training Services the different approaches to transfer are explored fully and case studies are used extensively to follow the process from review of the method prior to transfer, to creating a suitable protocol with relevant acceptance criteria, and evaluating the results generated to assess whether the transfer has been successful.