DIN EN ISO 15378-2007 药品的主要包装材料.以良好加工实践(GMP)为参考ISO9001-2000应用的特殊要求
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【英文标准名称】:Primarypackagingmaterialsformedicinalproducts-ParticularrequirementsfortheapplicationofISO9001:2000,withreferencetoGoodManufacturingPractice(GMP)(ISO15378:2006);GermanandEnglishversionENISO15378:2007
【原文标准名称】:药品的主要包装材料.以良好加工实践(GMP)为参考ISO9001-2000应用的特殊要求
【标准号】:DINENISO15378-2007
【标准状态】:现行
【国别】:德国
【发布日期】:2007-10
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;定义;易耗的包装;工业流程测量;锁上;制造;医疗产品;多语种的;不能重新盖紧的;包装件;包装;配药包装件;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);测试;测试条件
【英文主题词】:
【摘要】:ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovideprimarypackagingmaterialsformedicinalproducts,whichconsistentlymeetcustomerrequirements,includingregulatoryrequirementsandInternationalStandardsapplicabletoprimarypackagingmaterials.InthisInternationalStandardtheterm"/fappropriate"isusedseveraltimes.Whenarequirementisqualifiedbythisphrase,itisdeemedtobe"appropriate"unlesstheorganizationcandocumentajustificationotherwise.ISO9001:2000,Qualitymanagementsystems--Requirements1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationa)needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,andb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.NOTEInthisInternationalStandard,theterm"product"appliesonlytotheproductintendedfor,orrequiredby,acustomer.
【中国标准分类号】:C08
【国际标准分类号】:03_120_10;11_120_10;55_040
【页数】:155P.;A4
【正文语种】:多种语言
【原文标准名称】:药品的主要包装材料.以良好加工实践(GMP)为参考ISO9001-2000应用的特殊要求
【标准号】:DINENISO15378-2007
【标准状态】:现行
【国别】:德国
【发布日期】:2007-10
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;定义;易耗的包装;工业流程测量;锁上;制造;医疗产品;多语种的;不能重新盖紧的;包装件;包装;配药包装件;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);测试;测试条件
【英文主题词】:
【摘要】:ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovideprimarypackagingmaterialsformedicinalproducts,whichconsistentlymeetcustomerrequirements,includingregulatoryrequirementsandInternationalStandardsapplicabletoprimarypackagingmaterials.InthisInternationalStandardtheterm"/fappropriate"isusedseveraltimes.Whenarequirementisqualifiedbythisphrase,itisdeemedtobe"appropriate"unlesstheorganizationcandocumentajustificationotherwise.ISO9001:2000,Qualitymanagementsystems--Requirements1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationa)needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,andb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.NOTEInthisInternationalStandard,theterm"product"appliesonlytotheproductintendedfor,orrequiredby,acustomer.
【中国标准分类号】:C08
【国际标准分类号】:03_120_10;11_120_10;55_040
【页数】:155P.;A4
【正文语种】:多种语言
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