Quality by Design in Practice

Abstract The practice of Quality by Design (QbD) is a nonprescriptive approach to product and process development utilizing state-of-the-art-process analyzers, data acquisition, and data analysis tools. The main tools used for QbD are Design of Experiments (DoE), Multivariate Data Analysis (MVA), and the tools associated with Six Sigma. Only when product and process development are approached in a multivariate manner can real insights and knowledge management begin. This chapter describes how the modeling strategies of DoE and MVA are related to each other and describes how developed models can be integrated into Advanced Process Control (APC) systems that allow continuous verification and improvement strategies. The overall integration of process controls, process analyzers, data acquisition, and process modeling defines the overall Pharmaceutical Quality System as defined in ICH Q10.