智能制造理念在血液制品产业的应用研究  

Research on Application of Intelligent Manufacturing Concept in Blood Product Industry

作　　者：孙钟毓 李连 杜冉冉 刘瑞琛 李伟 曹大伟 臧恒昌[1] Sun Zhongyu;Li Lian;Du Ranran;Liu Ruichen;Li Wei;Cao Dawei;Zang Hengchang(School of Pharmaceutical Sciences,Shandong University,Jinan 250012,China;School of Basic Medical Sciences,Shandong University,Jinan Products Limited Company,Taian 271000,China）250012,China;Shandong Taibang BiologicalProducts Limited Company,Taian 271000,China)

机构地区：[1]山东大学药学院,济南250012 [2]山东大学基础医学院,济南250012 [3]山东泰邦生物制品有限公司,泰安271000

出　　处：《中国药事》2018年第9期1197-1206,共10页Chinese Pharmaceutical Affairs

基　　金：山东省自然科学基金项目(编号ZR2017MB012)

摘　　要：目的:通过分析智能制造理念下,质量源于设计(quality by design,QbD)与血液制品生产的相关性、过程分析技术(process analytical technology,PAT)在血液制品QbD中的应用以及关键质量环节的QbD实施,以期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:采取前瞻性研究方法,查阅、检索以"智能制造""血液制品""质量源于设计""过程分析技术"为关键词的文献,对智能制造理念在血液制品的应用研究进行论述。结果与结论: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,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。在科学监管的要求下,QbD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。Objective： To analyze the relationship between quality by design（QbD） and blood product production, the application of process analytical technology（PAT） in QbD of blood products and the implementation of QbD in the key quality links under the intelligent manufacturing concept so as to promote the upgrading of blood product industry in China and accomplish the intelligent production of blood products. Methods： Prospective research methods were used and literatures were consulted and retrieved using ＂intelligent manufacturing＂, ＂blood products＂, ＂quality by design＂ and ＂process analytical technology＂ as keywords to discuss the application of intelligent manufacturing concept in blood product industry. Results and Conclusion： Based on the level and status of automation and informatization of pharmaceutical industry in China, the ＂intelligent manufacturing＂ of the pharmaceutical industry has been gradually developed. QbD has been introduced into new version GMP of China, emphasizing the effective connection with drug registration and listing system. Due to requirements of scientific regulation, the concept of QbD had become the consensus of the blood product industry. The implementation of QbD and question-based review（QbR） will help to improve the quality and enhance the competitiveness of blood products.

关 键 词：智能制造 质量源于设计(QbD) 血液制品 过程分析技术(PAT) 关键质量环节 

分 类 号：R-1[医药卫生] TP29[自动化与计算机技术—检测技术与自动化装置]