Essentials in Quality By Design

摘要

Quality by design (QbD) is a systematic approach to drug development. It begins with predefined objectives and emphasizes product and process understanding and process control, all based on sound science, data-based decision making, and quality risk management (QRM). As introduced by the US Food and Drug Administration (FDA), QbD brings modern drug development methodologies to chemistry, manufacturing, and control (CMC) teams working on biologies, pharmaceuticals, and vaccines. The innovations associated with QbD are not so much the development concepts (which have been proven in multiple industries for well over 20 years). Rather, such innovations are the application of those principles in the development, submission, and manufacturing of drug products and drug substances.