By Daniel L. Kirschner, PhD, Executive Director, Analytical Services, and Tom Lovelace, Director, Process Development and API Manufacturing
Over the last decade, the FDA’s initiative to improve product safety through principles of Quality by Design (QbD) has spurred a transformation in manufacturing processes. The concept of using a control strategy to ensure product quality was originally devised to increase consumer safety, but following these guidelines also offers benefits to drug producers.
The application of QbD methods to process design yields better understanding of each step in product synthesis. With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process.