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【英文标准名称】:Primarypackagingmaterialsformedicinalproducts-ParticularrequirementsfortheapplicationofISO9001:2000,withreferencetoGoodManufacturingPractice(GMP)
【原文标准名称】:药品的主要包装材料.以优秀制造实践为基准对ISO9001:2000应用的特殊要求
【标准号】:ISO15378-2006
【标准状态】:作废
【国别】:国际
【发布日期】:2006-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC76
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;定义;可伸缩包装;工业流程测量;锁止的;制造;医疗产品;不可重新盖紧的;包装件;包装;配药包;药剂学;生产技术;采购;合格试验;质量;质量保证;质量管理;质量要求;安全;安全要求;规范(验收);监督(认可);试验;试验条件
【英文主题词】:Accidentprevention;Definitions;Expendablepackings;Industrialprocessmeasurement;Lock-up;Manufacturing;Medicaldevices;Medicalproducts;Multilingual;Non-reclosable;Packages;Packaging;Pharmaceuticpackages;Pharmacy;Productiontechniques;Purchasing;Qualificationtests;Quality;Qualityassurance;Qualitymanagement;Qualityrequirements;Safety;Safetyrequirements;Specification(approval);Surveillance(approval);Testing;Testingconditions
【摘要】:1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovideprimarypackagingmaterialsformedicinalproducts,whichconsistentlymeetcustomerrequirements,includingregulatoryrequirementsandInternationalStandardsapplicabletoprimarypackagingmaterials.InthisInternationalStandardtheterm“ifappropriate”isusedseveraltimes.Whenarequirementisqualifiedbythisphrase,itisdeemedtobe“appropriate”unlesstheorganizationcandocumentajustificationotherwise.ISO9001:2000,Qualitymanagementsystems—Requirements1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationa)needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,andb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.NOTEInthisInternationalStandard,theterm“product”appliesonlytotheproductintendedfor,orrequiredby,acustomer.1.2ApplicationThisInternationalStandardisanapplicationstandardforthedesign,manufactureandsupplyofprimarypackagingmaterialsformedicinalproducts.Itisalsoapplicableforcertificationpurposes.ISO9001:2000,Qualitymanagementsystems—RequirementsAllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.Whereanyrequirement(s)ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.Whereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganization'sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryrequirements.
【中国标准分类号】:A82;C10
【国际标准分类号】:11_120_99
【页数】:59P;A4
【正文语种】:英语