This paper outlines an innovative approach to pharmaceutical process development using advanced Design for Six Sigma (DFSS) supported by a knowledge management system. DFSS has been the toolkit of choice for many pharmaceutical companies when implementing the requirements of ICH Q8 Quality by Design. Here we will show how the Independence and Information Axioms and a Design Knowledge Matrix can be used to optimize the use of Design Of Experiments (DOE) and minimize risk, merging some of most innovative tools of the Design For Six Sigma toolbox to ensure patient safety while maintaining maximum flexibility for continuous process optimization.
Axiomatic Design in Pharmaceutical Process Development: Quality by Design
Arcidiacono G
2011-01-01
Abstract
This paper outlines an innovative approach to pharmaceutical process development using advanced Design for Six Sigma (DFSS) supported by a knowledge management system. DFSS has been the toolkit of choice for many pharmaceutical companies when implementing the requirements of ICH Q8 Quality by Design. Here we will show how the Independence and Information Axioms and a Design Knowledge Matrix can be used to optimize the use of Design Of Experiments (DOE) and minimize risk, merging some of most innovative tools of the Design For Six Sigma toolbox to ensure patient safety while maintaining maximum flexibility for continuous process optimization.| File | Dimensione | Formato | |
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ICAD-2011-Paper23-Schurr-and-Arcidiacono.pdf
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