Karen Gaudin

Quality by design (QbD) has gained in importance in the pharmaceutical industry and is supported by several regulatory documents (ICH, FDA). The aim is to ensure product quality through a better understanding of products and processes during pharmaceutical development. As analytical procedures are critical processes of pharmaceutical product development and quality control (QC), QbD has become a key tool in the development of analytical methods. This article outlines the general trends observed when applying QbD to the development of separation methods in pharmaceutical analysis. The main pharmaceutical applications are reviewed along with a detailed description of tools involved in QbD methodology. A focus on QbD benefits for the pharmaceutical industry is provided.