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ID:23716085
大小:523.50 KB
页数:46页
时间:2018-11-10
《英文版)药用包装材料质量标准is》由会员上传分享,免费在线阅读,更多相关内容在应用文档-天天文库。
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
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