vol4-chap1 pharmaceutical quality system 2012-06_en

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1、Ref.Ares(2012)778531-28/06/2012EUROPEANCOMMISSIONHEALTHANDCONSUMERSDIRECTORATE-GENERALHealthSystemsandProductsMedicinalProducts-Quality,safetyandefficacyBrussels,SANCO/AM/sl/ddg1.d.6(2012)860362EudraLexTheRulesGoverningMedicinalProductsintheEuropeanUnionVolume4EUGuidelinesf

2、orGoodManufacturingPracticeforMedicinalProductsforHumanandVeterinaryUseChapter1PharmaceuticalQualitySystemLegalbasisforpublishingthedetailedguidelines:Article47ofDirective2001/83/EContheCommunitycoderelatingtomedicinalproductsforhumanuseandArticle51ofDirective2001/82/EConth

3、eCommunitycoderelatingtoveterinarymedicinalproducts.Thisdocumentprovidesguidancefortheinterpretationoftheprinciplesandguidelinesofgoodmanufacturingpractice(GMP)formedicinalproductsaslaiddowninDirective2003/94/ECformedicinalproductsforhumanuseandDirective91/412/EECforveterin

4、aryuse.Statusofthedocument:revision3Reasonsforchanges:AmendmentstothetextofChapter1havebeenmadeinordertoalignwiththeconceptsandterminologydescribedintheICHQ10tripartiteguidelineonPharmaceuticalQualitySystem.Thetitleofthechapteritselfisalsochangedaccordingly.Deadlineforcomin

5、gintooperation:31January2013CommissionEuropéenne,B-1049Bruxelles/EuropeseCommissie,B-1049Brussel–Belgium.Telephone:(32-2)29911111PrincipleTheholderofaManufacturingAuthorisationmustmanufacturemedicinalproductssoastoensurethattheyarefitfortheirintendeduse,complywiththerequire

6、mentsoftheMarketingAuthorisationorClinicalTrialAuthorisation,asappropriateanddonotplacepatientsatriskduetoinadequatesafety,qualityorefficacy.Theattainmentofthisqualityobjectiveistheresponsibilityofseniormanagementandrequirestheparticipationandcommitmentbystaffinmanydifferen

7、tdepartmentsandatalllevelswithinthecompany,bythecompany’ssuppliersandbyitsdistributors.Toachievethisqualityobjectivereliablytheremustbeacomprehensivelydesignedandcorrectly1implementedPharmaceuticalQualitySystemincorporatingGoodManufacturingPracticeandQualityRiskManagement.I

8、tshouldbefullydocumentedanditseffectivenessmonitored.AllpartsofthePharmaceuticalQu