中国-欧盟药品质量相关法规研讨培训资料欧盟GMP的更新

《中国-欧盟药品质量相关法规研讨培训资料欧盟GMP的更新》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、05/07/2012UpdateonGMPintheEuropeanUnionEU-ChinaWorkshoponGMP/Pharmacopoeia/APIs11July2012,BeijingPresentedby:DavidCockburnHeadofManufacturingandQualityComplianceAnagencyoftheEuropeanUnion欧盟GMP的更新EU-ChinaWorkshoponGMP/Pharmacopoeia/APIs11July2012,Beij

2、ingPresentedby:DavidCockburnHeadofManufacturingandQualityComplianceAnagencyoftheEuropeanUnion1105/07/2012AgendaEUGMPRecentchangestoEUGMPQualityRiskManagementandGMPValidationDeviationsChangemanagementEudraGMPManufactureinChinaforEU2内容安排欧盟GMP欧盟GMP近年的变化

3、质量风险管理和GMP验证偏差变更管理欧盟法规集-GMP进入欧盟的中国生产商32205/07/2012GMPinEU:TodayPrinciplesandGuidelinesofGMPDirectives2003/94/ECand91/412/EECEUGMPGuidePart1EUGMPGuidePartIIDetailedGuidelinesforDetailedGuidelinesMedicinalProductsforActivesubstancesProvisionsforWholesa

4、leDistributionSupplementaryGuidelinesDirectives2001/82&3/ECAnnex1to19GoodDistributionPracticeEUGMPGuidePartIIIMiscellaneousGMP-relatedguidance4欧盟GMP:如今GMP的原则和指南指令2003/94/EC和91/412/EEC欧盟GMP指南第I部分欧盟GMP指南第II部分药品的具体指南活性物质的具体指南批发分销条款，指令2001/82&3/EC补充指南附件1

5、-19良好的药品流通质量管理规范欧盟GMP指南第III部分各种GMP相关指南53305/07/2012GMPinEU:Post-implementationof“FalsifiedMedicinesDirective”PrinciplesandGuidelinesofGMPPrinciplesandGuidelinesofGMPDirectives2003/94/ECand91/412/EECforActiveSubstancesEUGMPGuidePart1EUGMPGuidePartIIDe

6、tailedGuidelinesforDetailedGuidelinesforMedicinalProductsActivesubstancesProvisionsforWholesaleDistributionandBrokeringDirectives2001/82&3/ECSupplementaryGuidelinesAnnex1to19GoodDistributionPractice(revised)GoodDistributionEUGMPGuidePartIIIPracticeFo

7、rActiveMiscellaneousGMP-relatedguidance6substances欧盟GMP:”打击假药”指令实施后GMP的原则和指南原料药GMP的原则和指南指令2003/94/EC和91/412/EEC欧盟GMP指南第I部分欧盟GMP指南第II部分药品的具体指南活性物质的具体指南批发分销和中间商条款指令2001/82&3/EC补充指南附件1-19良好的药品流通质量管理规范(修订版)活性物质的流通质量管理规范欧盟GMP指南第III部分各种GMP相关指南74405/07/2012

8、EUGMPGuidePartI1.PharmaceuticalQualitySystemPartII=ICHQ72.Personnel3.PremisesandPartIII:Equipment•ICHQ94.Documentation•Q105.Production•MRABatchCertificate6.QualityControl7.OutsourcedActivities19Annexes8.ComplaintsandRecalls9.SelfInspection8欧盟GMP指南第I部