Using Qualitative Models to Capture and Demonstrate Process Understanding

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
2010 AIChE Annual Meeting
AIChE Annual Meeting
November 7, 2010 - 7:00pm
This presentation will cover how qualitative models can be used to capture and demonstrate process understanding and improve communication between disciplines, across geographical locations, languages and cultures both within, and between, organisations and regulators within a QbD framework. The presentation will highlight how the use of pictorial, information rich tools can improve learning between disciplines in order to bring the fundamental scientific ideas and concepts together. It will also demonstrate how to significantly reduce risks during scale-up through improved process understanding by incorporating both physical and chemical aspects into the models. This presentation will explain how the generation of qualitative models assessing separate aspects of the process, allows for structured yet rapid identification of process improvement options and key data gaps. It will also identify likely critical process parameters (CPPs) and provides a sound scientific rationale for where DOEs should be placed within the design space. Use of these qualitative models will also identify where the targeted use of advanced modelling tools and techniques will add most value.
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