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Experiment plan, an essential tool for pharmaceutical development with the Quality by Design approach

Presenter: Chung TRINH - Patheon (Thermofisher)

For the purpose of developing a product under control, experimental plans are one of the most important tools of the Quality by Design approach. Experimental plans are used to assess the impact of factors on product quality and to define a control strategy such as a design space to mitigate risks to product quality. An example of the development of the lamination process with two experimental plans following the identification of the risks of scuffing and spray drying. Using JMP's DoE & fit model function, the critical parameters (the root causes) are identified and the optimal parameters are selected to have a controlled and robust process.