By Shawn Watson, Head of Research and Development
The origins of pharmaceutical Quality by Design (QbD) can arguably be traced back to W. Edwards Deming’s book, Out of Crisis, first published in 1982. In the book, Deming introduced his fourteen points of management which have had a significant impact on how organizations pursue intended outcomes. Deming’s third point transformed how we achieve quality; not through a reliance on post-manufacturing testing, but by designing quality into products from the initial stages of development.
The FDA’s guidance concerning QbD began taking shape not long after I began working as a bench chemist, the first role I had in the pharmaceutical industry. QbD has always been a part of my professional life and I hold a strong belief that it begins in the early stages of drug development. It has also been continuously refined by FDA in coordination with industry and my own understanding has been continuously advanced through experience.
The concept of QbD asserts that quality be designed into a drug based on an understanding of the product and the process by which it is developed and manufactured. QbD is often discussed in the context of process development and manufacturing. However, this article focuses on how QbD is applied to research and development (R&D) to drive better results throughout the drug development process.