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.
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)
出处
《中国当代医药》
CAS
2024年第26期141-146,共6页
China Modern Medicine
关键词
药品研发
质量管理体系
数据可靠性
文件管理
Drug research and development
Quality management system
Data integrity
Document
