Marion Chatfield

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

A novel approach for assessing method robustness is described that uses risk-based assessment tools to identify, score, prioritise and then group method parameters.

This downloadable Failure Mode Effect Analysis tool accompanies the article titled 'The Application of Quality by Design to Analytical Methods' by Phil Borman et. al.

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.

This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).