Phil Nethercote is a director in New Product Support, Global Manufacturing Supply at GlaxoSmithKline (Ayrshire, UK).

Phil Nethercote

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

The merits of applying quality by design (QbD) to pharmaceutical products and processes is a topic of significant mutual interest to both pharmaceutical manufacturers and regulatory agencies. The pharmaceutical industry is currently embracing QbD concepts to help improve the robustness of manufacturing processes and to facilitate continuous improvement strategies to shape and enhance product quality and manufacturing productivity. As such, both industry and regulators recognize the benefits of adopting a QbD approach to drug-product development and manufacture, with key concepts described in International Conference on Harmonization (ICH) guidelines Q8(R1) 

Articles

Implications and Opportunities of Applying QbD Principles to Analytical Measurement

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.