注射剂型仿制药研发的质量风险及应对策略  

Investigation on the countermeasures of quality risk in the research and development of injectable generic drugs

作　　者：王烨 陈玉文[1] WANG Ye;CHEN Yuwen(College of Business Administration,Shenyang Pharmaceutical University,Liaoning,Shenyang 110016,China)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016

出　　处：《中国医药科学》2021年第18期143-146,共4页China Medicine And Pharmacy

摘　　要：注射剂型仿制药的研发面临着质量风险,如果能对注射剂型仿制药的研发过程进行质量风险管理,从而规避注射剂型仿制药研发质量风险,不仅可以提高研发效率,还可以提升产品获批率。通过对“人、机、料、法、环”5个质量风险因素进行识别,分析注射剂型仿制药研发过程中可能出现的质量风险及危害,从以下几个方面提出应对策略:做好人员的管理、加强仪器设备管理、完善物料管理、规范方法的建立、加强环境管理,为注射剂型仿制药研发工作者提供参考。The research and development(R&D)of injectable generic drugs is facing quality risks.If we can manage the quality risks in the R&D process of injectable generic drugs,so as to avoid the quality risks in R&D of injectable generic drugs,we can not only improve the R&D efficiency,but also improve the product approval rate.By identifying the five quality risk factors of"personnel,equipment,material,method and environment",this paper analyzes the possible quality risks and hazards in the R&D of injectable generic drugs and puts forward some countermeasures from the following aspects.We should do a good job in personnel management,strengthening equipment management,improving material management,establishing standardized methods and enhancing environmental management,so as to provide reference for R&D workers of injectable generic drug s.

关 键 词：注射剂型仿制药研发 质量风险 风险因素 风险识别 应对策略 

分 类 号：R95[医药卫生—药学]