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Quality by Design

Originating from the automotive sector Quality by Design is a key-concept to plan product quality and avoid quality crises in advance. Nowadays even the FDA (Food and Drug Administration) appreciates this methodology and recommends QbD for the way how drug discovery, development and commercial manufacturing could be done. Thus since several years the FDA “pushes” to advance knowledge-based processing to open up a big opportunity to a new level of understanding and process performance.


Generally flow processing allows a significant step towards knowledge-based processing and thus enables a paradigm shift. At first mainly influencing a conceptual change and moving from a process which is optimized for a specific batch vessel towards a continuous process where the tools are adjusted according to the special process needs. Secondly linking all important critical process parameters to each quality parameter and measure them by appropriate instruments known as Process Analytical Technologies (PATs). Therefore a standard procedure for flow processes for identifying of Critical Process Parameter (CPP) and linking them to Critical Quality Parameters (CQP) needs to be developed, which is called Quality by Design.


“Critically scrutinizing all links between product quality and critical process parameters - finally arriving safely at the desired product with highest quality”



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