Articles by Marion Chatfield - Pharmaceutical Technology

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Articles by Marion Chatfield

Marion Chatfield


Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline.

Articles
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach
October 2, 2014

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

Reduced-Method Robustness Testing of Analytical Methods Driven by a Risk-Based Approach
April 2, 2010

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

Reduced method robustness testing of analytical methods driven by a risk-based approach
March 30, 2010

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

FMEA tool
October 11, 2007

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.

The Application of Quality by Design to Analytical Methods
October 2, 2007

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).

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