(138e) QbD – More Than Just An Acronym

To borrow from Aristotle, the whole of quality by design (QbD) is more than the sum of its parts.  It is more than target product profiles and critical quality attributes.  More than critical process parameters and design spaces.  More than process analytical technologies and control strategies.  This is not to suggest that these individual elements are devoid of value.  Rather, it is in this systematic approach that pharmaceutical companies can fully realize the benefits proffered by QbD.  This presentation will provide a case study where a holistic QbD approach was applied to development of a blended powder-in-capsule oral dosage form and how this approach led to more efficient utilization of resources, reduction of costs associated with development and commercial scale-up, and ultimately better product and process understanding.