摘要
随着目前临床上用于治疗的药品种类越来越丰富,制药企业数量也随之增加。但是随着近年来药品不良事件的频繁发生,人们对用药的安全意识也不断增强。在药品生产企业的日常生产工作中,质量风险管理具有重要的意义,并且随着新版GMP的发布,也将药品的质量风险管理提升到更为重要的地位。因此,对药品生产企业中质量风险管理的应用进行研究探讨具有重要的意义。
With the increasing variety of drugs currently used clinically,the number of pharmaceutical companies has also increased.However,with the frequent occurrence of adverse drug events in recent years,people’s awareness of the safety of medication is also increasing.In the daily production of pharmaceutical manufacturers,quality risk management is of great significance,and with the release of the new version of GMP,the quality risk management of pharmaceuticals is also promoted to a more important position.It is of great significance to study and discuss the application of quality risk management in pharmaceutical manufacturers.
出处
《化工设计通讯》
CAS
2020年第2期192-193,共2页
Chemical Engineering Design Communications
关键词
质量风险管理
药品生产企业
作用
quality risk management
pharmaceutical manufacturing enterprise
role
