Quality by Design (QbD) is a proactive, science-based approach to pharmaceutical and biopharmaceutical development that emphasizes building quality into a product and its manufacturing process from the outset, rather than relying solely on end-product testing. Defined within ICH Q8, ICH Q9, ICH Q10, and ICH Q11 guidelines, QbD employs systematic tools including the Quality Target Product Profile (QTPP), critical quality attribute (CQA) identification, risk assessment, Design of Experiments (DoE), design space definition, and control strategy development to ensure process robustness, regulatory flexibility, and product consistency throughout the product lifecycle.
