Quality by Design
Bruce S. Davis · 2013
The term quality by design (QbD) is increasingly used in the pharmaceutical industry and normally describes a science- and risk-based approach to developing and manufacturing pharmaceutical products, based on the principles laid out in the International Conference on Harmonization (ICH) guidances. There are several stages in developing a new product using a QbD methodology. These stages are applicable in principle whether the products are small or large molecules. The principle steps based on Q8R2 start with patient safety and efficacy requirements, to ensure the final drug product meets quality requirements. This chapter describes the main steps for a quality by design approach for a new product. Some examples of QbD approaches for small molecule and large molecule products are also listed.