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Quality by design (QbD) is a concept first developed by the quality pioneer Dr. Joseph M. Juran (1). Dr. Juran believed that quality should be designed into a product, and that most quality crises and problems relate to the way in which a product was designed in the first place.

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QbD can be viewed as a process defined by series of document requirements. These documents organize and demonstrate process knowledge and understanding. QbD can be applied to legacy and new products, but the supporting document package may differ. The QbD suite of documents are “alive”. They can and should be revised as the knowledge base changes.

In this new context, early risk assessment, using developability methodologies and computational methods in particular, can assist in reducing risks during development in a cost-effective way.

Example QbD IR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development April 2012 5 of extragranular talc and magnesium stearate on drug product CQAs.

QbD proposal is systematic, relating mechanistic understanding of critical material attributes and critical process parameters to drug product critical quality attributes (CQAs). To achieve this goal, multivariate DOE-based experiments are encouraged.

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