Successful Control Strategies (Part 1)

Case study

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. A robust GMP manufacturing process can pay dividends in both time and cost efficiency, all while aligning the process to fulfil regulatory filing requirements.

In part one of our case study, learn how Cambrex applies exceptional analytical methods to ensure that quality of the end product is designed at the front end of the process. Our combination of our world-class facilities and the experience of our pharma-trained scientists gives us a competitive edge in demonstrating complete control of a manufacturing process during regulatory filing.