制药企业迎接GMP检查工作探讨  

Discussion of Pharmaceutical Companies Meeting GMP Inspection Work

作　　者：张颖 Zhang Ying(Center for Drug Inspection of Heilongjiang,Harbin 150076)

机构地区：[1]黑龙江省药品审核查验中心,哈尔滨150076

出　　处：《黑龙江医药》2022年第4期800-803,共4页Heilongjiang Medicine journal

摘　　要：2021年5月24日国家药监局颁布《药品检查管理办法(试行)》,明确了药品检查一系列规范和程序。现结合该管理办法、新版《药品生产质量管理规范》(GMP)、相关药品的法律法规以及作者的工作经验,从GMP现场检查的工作程序、GMP检查的具体过程方面探讨制药企业如何迎接GMP检查工作,以期为企业做好该项工作提供参考。On May 24th 2021,the State Food and Drug Administration promulgated the“Administrative Measures for Drug Inspection(Trial)”,which clarified a series of specifications and procedures for drug inspection.Combining this management file,the New version of Good Manufacturing Practice(GMP),the related laws and regulations of drugs,and the author’s work experience,we discusses how pharmaceutical companies can meet GMP inspectionfrom the working procedures and process,in order to provide reference for the companies to do this work well.

关 键 词：药品检查 新版GMP 制药企业 

分 类 号：R95[医药卫生—药学]