Product and process development applying Quality by Design and Design of Experiment concepts to define 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.
See the full recording of the webcast ‘Multiparticulates 5 – Product and process development applying QbD (quality by design) and DoE (design of experiments) concepts to define DS (design space)‘ here!
Have a look at a selection of the webinar Q+A here:
Q1: “What could be the best practice to determine the PSD of the API depending on the QbD approach?”
Q2: “In the example given, could be the choice of filter bag critical? If so, what would you do about this?”
Q3: “Is the dew point critical in the process?”
Q4: “How many Design of Experiment is necessary to get a flexible and robust formulation?”
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