新型的药品质量管理理念_质量源于设计_.pdf

* 100050 Quality-by-designQbD Quality-by-testingQbT QbT QbD ICH Q8 Q9 Q10 QbD QbT QbD A new concept of pharmaceutical management systemquality-by-design QbD WANG Ming-juan, HU Xiao-ru, DAI Zhong*MA Shuang-cheng (National Institutes for Food and Drug control, Beijing 100050, China) Abstract: To ensure the clinical performance (safety/efficacy) of a drug product suitable for its intended use, quality-by-design (QbD), a new pharmaceutical quality management system, uses a different approach from the current quality-by-testing (QbT) system. QbD focuses on the full understanding of pharmaceutical formulations and their manufacturing processes, identification of critical quality attributes (CQAsand critical process parameters (CPPs) based on the results of quality risk management process, application of science- and risk-based control strategy to minimize the quality risks within acceptable ranges. In this paper, key contents described in ICH Q8 (Pharmaceutical development), Q9 (Quality risk management) and Q10 (Pharmaceutical quality system) guidelines, differences between QbD and QbT systems and potential applications of QbD principles to improve the current QbT system were reviewed to provide valuable * Tel: 86-10 e-mail: daizhong@ enlightenments to apply QbD in Chinese quality control system of pharmaceuticals. Key words: quality-by-designQbD; pharmaceutical quality control;quality risk management; control strategy 2001 Food and Drug AdministrationFDA Quality-by-design, QbDQbD