Process Excellence: Five Critical Elements of Quality By Design

Life-science companies that adopt “quality by design” (QbD) into their overall operations are expected to achieve the “desired state” of manufacturing. So concludes the Q10 document from the EMEA, US FDA, and the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use. The ability to achieve an appropriate quality outcome must be designed into each manufacturing process rather than companies relying on final product testing.