QbD Lifecycle Management for Analytical Methods

20 - 21 June 2013, Newhouse, Lanarkshire, United Kingdom

Introduction

A QbD and lifecycle management approach to analytical method development and qualification will result in a better understanding and fewer failures of analytical methods due to more robust methods which produce consistent, reliable, quality data throughout the lifecycle. This, in turn, will lead to less method transfer failures, OOS results and method "incidents" when used in the routine environment. As the industry is now applying Quality by Design (QbD) to process development, it is now being recognized that this is also the way forward to improve and standardise our approach to analytical procedures.