Quality by Design for Analytical Methods

Nethercote, Phil; Ermer, Joachim
October 2012
Pharmaceutical Technology Europe;Oct2012, Vol. 24 Issue 10, p52
Trade Publication
Adoption of quality-by-design (QbD) concepts in pharmaceutical development and manufacture is becoming increasingly well-established. QbD concepts are aimed at improving the robustness of manufacturing processes based upon adopting a systematic and scientific approach to development and implementing a control strategy based on the enhanced process understanding this provides. Many pharmaceutical companies have also recognised that QbD concepts can be used to improve the reliability of analytical methods. The authors describe how traditional approaches to analytical method transfer and validation may also benefit from alignment with QbD concepts and propose a three-stage concept to ensure that methods are suitable for their intended purpose throughout the analytical lifecycle: method design, method qualification and continued method verification. This paper represents a refinement and enhancement of the concepts originally proposed in an article written by P. Nethercote, T. Bennett, P. Borman, G. Martin and P. McGregor (1).


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