Pharmaceutical Technology: Applying QbD in Process Development

By Andrew Anderson, Graham A. McGibbon, Sanjivit K. Bhal

Published online at Pharmaceutical Technology, Sept. 2017.

Over the past few years, global regulatory authorities have been raising the expectation of incorporating quality by design (QbD) into pharmaceutical development. While QbD offers many important long-term benefits, these expectations are having a dramatic impact on product development groups and their supporting corporate informatics infrastructure. This article discusses how QbD requirements for risk assessment, process assessment, material assessment, documentation, and traceability can be addressed with informatics, using development of an impurity control strategy as an example.