Abstract

Quality by Design (QbD) means that, starting from the very first development step, products and processes are designed in a way to ensure a high level of quality and reliability. One of the main QbD tools is statistical Design of Experiments (DoE), which enables to perform the necessary experiments in an efficient and structured way. This constitutes the most effective manner to identify the Critical Process Parameters (CPP’s) and Material Attributes (CMA’s) that, together, influence most the quality characteristics of highest concern, the so-called Critical Quality Attributes (CQA’s). Of course, the methodology can also be applied to optimize existing products or processes.