The key components of the QbD concept, namely, the Design Space and PAT, do draw extensively for their realization on tools from the domain of process systems engineering methodology. Both the challenges and the opportunities in adapting core PSE methodology, such as process modeling and simulation, process dynamics and control, monitoring and fault diagnosis, quantification of process uncertainty and risk, and product and process optimization, to the development and manufacture of pharmaceutical products are significant. In this presentation we will review the progress made in the application of pse methods to this domain and outline some of the important developments that remain to be realized.
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