Building a Framework for Quality by Design

Driven by greater global competition and the growing impact of information technology, the pharmaceutical industry faces a need to improve its performance. Speed to market, product quality, regulatory compliance, cost reduction, waste, and cycle time are among the concerns that must be addressed in a systematic, focused, and sustainable manner. Quality by design (QbD), an approach offered by the US Food and Drug Administration, provides an effective tool for addressing these concerns. This article discusses the key steps for implementing QbD by providing a focus on how to develop the process understanding that leads to a useful design space, process-control methods, and characterization of process risk. Product and process life-cycle model validation is also addressed. Integrating these concepts provides a holistic approach for effectively designing and improving products and processes from the development of an active pharmaceutical ingredient to its manufacture and for other pharmaceutical processes.