Table of Contents
Bioengineering, Volume 4, Issue 4 (December 2017)
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Cover Story (view full-size image) Pharmaceutical manufacturing aims to deliver products with consistently high quality. Therefore, [...] Read more. Pharmaceutical manufacturing aims to deliver products with consistently high quality. Therefore, process parameters, which are critical to the product quality, need to be identified and controlled. State of the art is to solely control the known risk (i.e. statistically significant parameters). Here, we present a statistical approach to set up control strategies for potentially overlooked parameters (potential risk). Thereby, it is possible to reduce process variance, increase product quality and reduce patient risk. View this paper