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 relat-ed 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 re-search 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
Key words
Drug research and development/Quality management system/Data integrity/Document
维普
万方数据