EU GMP Annex 15 Qualification and Validation

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1、EUGMPannex15QualificationandValidation(draft)Brussels,6February2014SANCO/TSE/Thereceivedcontributionstogetherwiththeidentityofcontributorswillbemadepubliclyavailable,unlessthecontributorobjectstopublicationofhisorherpersonaldataonthegroundsthatsuchpublicationwouldharmhisorherlegiti

2、mateinterests.Inthiscasethecontributionmaybepublishedinanonymousform.Otherwisethecontributionwillnotbepublishednorwill,inprinciple,itscontentbetakenintoaccount.Formoreinformationontheprocessingofyourpersonaldatainthecontextofthisconsultation,readthespecificPrivacyStatementavailable

3、at:linktoPrivacyStatementEudraLexTheRulesGoverningMedicinalProductsintheEuropeanUnionVolume4EUGuidelinesforGoodManufacturingPracticeforMedicinalProductsforHumanandVeterinaryUseAnnex15:QualificationandValidation欧盟人用及兽用药品GMP指导原则附件15：确认和验证Legalbasisforpublishingthedetailedguidelines:A

4、rticle47ofDirective2001/83/EContheCommunitycoderelatingtomedicinalproductsforhumanuseandArticle51ofDirective2001/82/EContheCommunitycoderelatingtoveterinarymedicinalproducts.Thisdocumentprovidesguidancefortheinterpretationoftheprinciplesandguidelinesofgoodmanufacturingpractice(GMP)

5、formedicinalproductsaslaiddowninDirective2003/94/ECformedicinalproductsforhumanuseandDirective91/412/EECforveterinaryuse.Statusofthedocument:Revision1文件状态：修订Page29/29EUGMPannex15QualificationandValidation(draft)Proposeddocumenttimetable:DeadlineforcommentsonthedraftconceptpaperFebr

6、uary2013DraftguidelinediscussionintheGMDPIWGJune2013DraftguidelinediscussionwithothergroupsJune-September2013CommentsbyGMDPIWGandPIC/SOctober2013AdoptionofFinalDraftforpublicconsultation-DelayedduetoadditionalGMDPIWGcomments2014(November2013)-JanuaryStartofpublicconsultation-delaye

7、d(December2013)-February2014Endofpublicconsultation(deadlineforcomments)(March2014)-May2014Re-discussioninGMDPIWGSeptember2014ExpectedadoptionbyECOctober2014Reasonsforchanges:UpdateasperconceptpaperonrevisionofAnnex15.Summaryofchanges:Thischangetoannex15takesintoaccountchangestooth

8、ersectionsoftheEU-GMPGuide