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1、0Introduction0.1GeneralThisinternationalstandardidentifiesGoodManufacturingPractice(GMP)principlesandspecifiesrequirementsforaqualitymanagementsystemapplicabletoprimarypackagingmaterialsformedicinalproducts.TherealizationofGMPprinciplesinproductionandco
2、ntrolofprimarypackagingmaterialswithinorganizationsisofgreatimportanceforthesafetyofapatientusingthemedicinalproduct,becauseoftheirdirectproductcontact.TheapplicationofGMPforpharmaceuticalpackagingmaterialsshouldensurethatthesematerialsmeettheneedsandre
3、quirementsofthepharmaceuticalindustry.ThisinternationalStandardisanapplicationstandardforprimarypackagingmaterialswhichcontainstherequirementstextofISO9001:2000.TheconventionsforthelayoutofthisInternationalStandardarethefollowing.—Thoseclausesorsubclass
4、esthatarequoteddirectlyandunchangedfromISO9001:2000areincoxedtext.—TextsinitalicscontainadditionallyrelevantGMPrequirementsforprimarypackagingmaterials.—GMPtermsanddefinitionsareincludedinClause3.Iflisted,thesourceisreferredtoinbrackets.ISO9001:2000,Qua
5、litymanagementsystems—Requirements0.1GeneralTheadoptionofaqualitymanagementsystemshouldbeastrategicdecisionofanorganization.Thedesignandimplementationofanorganization'squalitymanagementsystemisinfluencedbyvaryingneeds,particularobjectives,theproductspro
6、vided,theprocessesemployedandthesizeandstructureoftheorganization.ItisnottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.ThequalitymanagementsystemrequirementsspecifiedinthisIntern
7、ationalStandardarecomplementarytorequirementsforproducts.Informationmarked“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.ThisInternationalStandardcanbeusedbyinternalandexternalparties,includingcertificationbodies,toassesstheorgan
8、ization'sabilitytomeetcustomer,regulatoryandtheorganization'sownrequirements.ThequalitymanagementprinciplesstatedinISO9000andISO9004havebeentakenintoconsiderationduringthedevelopmentofthisInternationalStandard.Akeyobjectiveofthis