实施新版药品GMP对医药生产企业的影响研究  

Research on Impact of Implementation of New Drug GMP on Pharmaceutical Production Enterprises

作　　者：廖瑞斌[1] 翁开源[1] 张琦[1] 

机构地区：[1]广东药学院,广东广州510730

出　　处：《广州化工》2015年第13期38-40,共3页GuangZhou Chemical Industry

摘　　要：为了更好地了解新版GMP对医药生产企业的影响,笔者综合运用面谈采访、实地考察、调查统计分析等研究方法,从多个角度对我国多个地区不同类型的医药生产企业进行分析,深入研究了法规调整对我国医药生产企业的影响方式、范围及结果,揭示了生产企业在实施新版药品GMP规范过程中较突出的问题及现象,为我国GMP规范调整的下一步工作奠定了基础,同时也为完善药品管理提出了一些意见。In order to have a better understanding of the effect of the new version of GMP in pharmaceutical production enterprises,interviews,site visits,investigation and statistical analysis research methods were used to analyze the different types of medicine production enterprises in different regions of China from multiple angles,the influence mode,scope,and results of the adjustment of laws and regulations of pharmaceutical production enterprises in China were in- depth studied to reveal more prominent problems and phenomena during the new edition GMP standard implementation process of the production enterprises,and laid the foundation for China＇s GMP next step adjustment. Some opinions to improve the drug management were also put forward.

关 键 词：新版药品GMP 医药生产企业 影响研究 

分 类 号：R951[医药卫生—药学]