药品研发质量管理体系的构建与思考  

Construction and thinking of quality management system in research and development of drug

作　　者：郝兴平 孙成金 庞宇 徐静 HAO Xingping;SUN Chengjin;PANG Yu;XU Jing(Department of Quality Management,National Vaccine&Serum Institute,Beijing101111,China)

机构地区：[1]国药中生生物技术研究院有限公司质量管理部,北京101111

出　　处：《中国当代医药》2024年第26期141-146,共6页China Modern Medicine

摘　　要：随着我国制药行业改革,国家药品监督管理局推出一系列的创新改革方案,推动了新药的快速获批,新药创制正迎来前所未有的发展机遇。在新法规新监管的环境下,药品研发机构建立和完善合规的质量管理体系是保证药品研发质量和成功注册的基础。本文梳理了药品研发相关的要求,结合研发质量管理体系构建的过程实践,从质量文化、质量培训、质量管理制度、文件和记录管理、仪器设备管理、物料管理、偏差处理与变更控制等方面提出了相应的质量管理建议,以期为研发质量管理体系构建提供参考。With the reform of China's pharmaceutical industry,National Medical Products Administration has launched a series of innovative reform programs,which has promoted the rapid approval of new drugs,and the creation of new drugs is having unprecedented opportunities for development.Under the environment of new laws and regulations,the establishment and improvement of compliant quality management system for drug research and development institutions is the basis for ensuring the quality of drug research and development and successful registration.This paper combs the requirements related to drug research and development,and combines the process practice of constructing research and development quality management system,and puts forward corresponding quality management suggestions from the aspects of quality culture,quality training,quality management system,document and record management,instrument and equipment management,material management,deviation treatment and change control,etc.,in order to provide reference for the construction of research and development quality management system.

关 键 词：药品研发 质量管理体系 数据可靠性 文件管理 

分 类 号：R951[医药卫生—药学]