Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Phil Borman

A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high‑performance liquid chromatography without having to prepare standards. The authors discuss the approach taken to develop the tool, its associated protocols and how it can be used to calculate data.

Articles

A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.

Quantitative open-access HPLC analysis: a new calibration approach

Please refer to the full online version of this article, located 

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

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) 

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.