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Mar
18
Multiparticulates 5 – Product and process development applying QbD (quality by design) and DoE (design of experiments) concepts to define DS (design space)
The QbD (quality by design) approach is a modern concept for the development of pharmaceutical products and manufacturing processes aiming for a consistent reproducible quality. Risk assessment is performed at defined milestones in order to define critical aspects of product composition and manufacturing processes. The DoE (design of experiment) concept is applied to quantitatively evaluate processing impacts on the product quality. Finally, a DS (design space) for manufacturing parameters within which process variations are possible without the need to re-validate a process is described and registered. Case studies demonstrate how the QbD approach can be applied in practice.