欧盟GMP现场检查条款.docx

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1、EUcGMPAUDITCHECKLISTDATE：CLIENTNAME：AUDITORS：SITEADDRESS：TYPEofACTIVITY(cGMPorPAI)：APPLICABLESECTIONSOBSERVATIONyesNOCOMMENTSIntroductionThepharmaceuticalindustryoftheEuropeanUnionmaintainshighstandardsofqualityassuranceinthedevelopment,manufactureandcontrolofmedicin

2、alproducts.Asystemofmarketingauthorisationsensuresthatallmedicinalproductsareassessedbyacompetentauthoritytoensurecompliancewithcontemporaryrequirementsofsafety,qualityandefficacy.AsystemofmanufacturingauthorisationsensuresthatallproductsauthorisedontheEuropeanmarket

3、aremanufacturedonlybyauthorisedmanufacturers,whoseactivitiesareregularlyinspectedbythecompetentauthorities.ManufacturingciuthorisationsarerequiredbyallpharmaceuticalmanufacturersintheEuropeanCommunitywhethertheproductsaresoldwithinoroutsideoftheCommunity.Twodirecfive

4、slayingdownprinciplesandguidelinesofgoodmanufacturingpractice(GMP)formedicinalproductswereadoptedbytheCommission・birective2003/94/ECappliestomedicinalproductsforhumanuseandbirective91/412/EECforveterinaryuse.Detailedguidelinesinaccordancewiththoseprinciplesarepublish

5、edintheGuidetoGoodManufacturingPractice,APPLICABLESECTIONSOBSERVATIONyesNOCOMMENTSwhichwillbeusedinassessingapplicationsformanufacturingauthorisationsandasabasisforinspectionofmanufacturersofmedicinalproducts.TheprinciplesofGAAPandthedetailedguidelinesareapplicableto

6、alloperationswhichrequiretheauthorisationreferredtoinArticle40ofDirective2001/83/ECandinArticle44ofDirective2001/82/EC,asamendedbyDirectives2004/27/ECand2004/28/EC.respectively.Theyarealsorelevantforallotherlargescalepharmaceuticalmanufacturingprocesses,suchasthatund

7、ertakeninhospitals,andforthepreparationofproductsforuseinclinicaltrials.AllMemberStatesandtheindustryagreedthattheGMPrequirementsapplicabletothemanufactureofveterinarymedicinalproductsarethesameasthoseapplicabletothemanufactureofmedicinalproductsforhumanuse.Certainde

8、tailedadjustmentstotheGMPguidelinesaresetoutintwoannexesspecifictoveterinarymedicinalproductsandtoimmunologicalveterinarymedicinalp