质量管理在药品研发过程中的应用

Application of the quality management in drug research and development

目的:为药品研究机构建立项目质量管理体系提供参考。方法:运用项目分解的方法,以《药品管理法》、《药品注册管理办法》和《药品生产质量管理规范》(GMP)为依据,针对药品研发的不同阶段提出了相应的管理重点及目标。结果与结论:质量首先是设计出来的,研发阶段的质量管理水平决定了最终产品的质量,规范化的管理、建立并执行良好的研发质量管理体系是优质产品诞生的必要条件。

Objective ：The study was aimed at the quality management which the department of drug R＆D wanted to build. Meth- ods ： The method of project breakdown was used. The key-point emphasis and the target in different stage were put forward according to the（（Drug Administration Law））, （（Provision for Drug Registration）） and （（Good Manufacture Practice））（GMP）. Results ＆ Conclu- sions：The product quality was designed firstly. The quality of the termination product was determined by the level of management in R＆D stage. The idea of canonical management and Client-Centered were the guarantee of high quality product.