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Extending the Boundaries of QbD

Published 02 June 2015 | By Malvern Panalytical

The last decade has seen a shift within the pharmaceutical industry towards a design space approach to development and manufacture, an agenda underpinned by ICHQ8, Q9 and Q10 and the concept of Quality by Design (QbD). However, because a design space approach naturally focuses attention on the areas of a project that are potentially the most vulnerable to failure it has broader value for risk management.

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Extending the Boundaries of QbD