Chapter 10 - Risk assessment and design space consideration in analytical quality by design

Abstract

Quality by design (QbD) is “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” Nowadays, QbD is a foremost prototype protocol in pharmaceutical industry to achieve quality products, besides safety and efficacy. It was mandated by US Food and Drug Administration (USFDA) in order to reduce the product recalls and six sigma (99.9999%) quality in the marketed products, it means QbD can significantly reduce the out-of-trend results, out-of-specification results, out-of-control, and out-of-statistical-control. In addition to USFDA, Europe Medicines Agency and International Council on Harmonization (ICH) guidelines such as ICH Q8 (R1) guideline made mandate to pharmaceutical industry through “design space.” It indicated that product and process performance characteristics must be scientifically designed as design space. In addition to ICH Q8, quality risk management (ICH Q9) and the development and manufacture of drug substances (ICH Q11) have also marked the need of QbD.