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Informatics for QbD

Published online at Chemistry & Industry, Dec. 2017.

In this article published by Chemistry & Industry, Andrew Anderson looks at some of the challenges that can be addressed with informatics solutions.

Increased expectations of health authorities and other regulatory bodies, to incorporate Quality-by-Design (QbD) are having a dramatic impact on product development groups and their supporting coporate informatics infrastructure.

One impact is the requirement for control justification strategies and rationales to achieve the Quality Target Product Profile (QTPP); and the necessary assessment of critical quality attributes for substances and formulated products intended for human consumption and medicinal use. Specifically, for each unit operation in any manufacturing process—whether it be synthetic steps in a chemical process; addition of ingredients; stirring or agitation, and heating or chilling, say in a food or beverage production line; or formulation steps during consumer product production—developers are expected to perform a concerted risk assessment.

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