【作者】 孙钟毓； 李连； 李伟； 杜冉冉； 刘瑞琛； 臧恒昌；

【Author】 Sun Zhongyu;Li Lian;Li Wei;Du Ranran;Liu Ruichen;Zang Hengchang;School of Pharmaceutical Sciences, Shandong University;School of Preclinical Medicine,Shandong University;Shandong Taibang Biological Products Limited Company;

【机构】 山东大学药学院； 山东大学基础医学院； 山东泰邦生物制品有限公司；

【摘要】 目的:基于我国制药工业的自动化与信息化的水平与现状,制药工业的"智能制造"已逐步发展起来,力求利用QbD理念设计提高产品质量,不断推动我国血液制品行业升级,实现血液制品的智能生产。方法:质量源于设计(quality bydesign,QbD)已被引入我国新版药品GMP,强调了与药品注册、上市制度的有效衔接。近年来,在科学监管的要求下,质量源于设计的理念已成为血液制品行业界的共识,实施QbD,通过基于问题的审核(question-based review,QbR),将有助于全面提高我国血液制品的质量,提升产品的竞争力。讨论与建议:本文综述了QbD与血液制品生产的相关性、过程分析技术(processanalytical technology,PAT)在血液制品QbD中的应用以及关键质量环节的QbD实施。更多还原

【Abstract】 Objective: Based on the level and status of automation and informatization in Chinese pharmaceutical industry, the "intelligent manufacturing" of the pharmaceutical industry has been gradually developed. For improving the quality of products, steadily pushing forward the blood products industry upgrade and accomplishing the intelligent production of blood products. Methods: Quality by design(QbD) has been introduced into new version GMP of China, emphasizing the effective connection with drug registration and listing system. In recent years, in the requirements of scientific supervision, the concept of QbD has become the consensus of the blood products industry. The implementation of QbD, through question-based review(QbR), will help to improve the quality and enhance the competitiveness of blood products. Discussion and suggestions: This paper reviews the relationship between QbD and blood products production, the application of process analytical technology(PAT) in QbD of blood products and the implementation of QbD in the key quality links.更多还原