9-2 EDQM对欧盟GMP的要求和原料药厂商检查-2 英文.pdf

下载文档 降价啦

55
0
约3.71万字
约 45页
2017-05-30 发布于河南
举报
版权申诉
保障服务

9-2 EDQM对欧盟GMP的要求和原料药厂商检查-2 英文.pdf

1、本文档共45页，可阅读全部内容。
2、有哪些信誉好的足球投注网站（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。

9-2 EDQM对欧盟GMP的要求和原料药厂商检查-2 英文

EU GMP reEU GMP reEU GMP reEU GMP reqqqqqqqquirements and insuirements and insuirements and insuirements and insppppppppections of APIections of APIections of APIections of API manufacturers organized by EDQMmanufacturers organized by EDQMmanufacturers organized by EDQMmanufacturers organized by EDQM ShanghaiShanghai,ShanghaiShanghai,, 29, 2929 June29 JuneJune 2012June 201220122012 FlFlFlFlorenceorence BBBBenoenoitititit--GGGGuyouyodddd,, EDQMEDQMEDQMEDQM IIIInspecnspecttttoorr Certification of Substances Division, EDQMCertification of Substances Division, EDQM OOOOvveeeervirvieeeeww • The EU GMP for APIs • International API inspection programme • What’s new ? • MainMain deficienciesdeficiencies • Statistics: activity review, compliance trendds Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 2 ResRespppponsibilitonsibilityyyy of the marketin of the marketingggg authorisation holderauthorisation holder (MAH)(MAH) of the medicineof the medicine • APIs must be produced according to EU GMP (Directives(Directives/8383/EC/EC andand/8282/EC/EC)) • It is the responsibility of the manufacturer to ensureensure EUEU GMPGMP compliancecompliance ofof thethe activeactive substance manufacturer • DDecllaratition off ththe QQualifilifiedd PPerson (QP) off ththe manufacturer in the marketing application (and subbsequentt variiatition)) Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 3 RoleRole of the Nationalof the Natio