ISO22716标准(中英文对比)ISO22716标准(中英文对照)1INTERNATIONASTANDARDL国际标准ISO22716Firstedition2022-11-15第一版本发行于2022年11月15日CosmeticsGoodManufacturingPractices(GMP)GuidelinesonGoodManufacturingPractices化妆品良好生产规范（GMP）准则ISO22716:2022(E)标准号ISO22716:2022(E)-2ContentsPageIntroduction(1)1Scope(1)2Termsanddefinitions(1 得量值，或事物量具或参考事物表示得值，和按标准实现得相应值间建立起一种关系 2.7changecontrol变更控制internalorganizationandresponsibilitiesrelativetoanyplannedchangeofoneorseveralactivitiescoveredbytheGoodManufacturingPracticesinordertoensurethatallthemanufactured,packaged,controlledandstoredproductscorres。
esearrangementsareimplementedeffectivelyandaresuitableforachievingobjectives由内部有能力得人员实施得系统和独立得检查，目得是为了确定活动是否覆盖了与指南和策划得相关结果，以及这些安排是否的到有效实施并适用于实现目标 2.18majorequipment主要设备equipmentspecifiedinproductionandlaboratorydocumentswhichisconsideredessentialtotheprocess在生产和实验室文件中详细说明得，被 认为是对加工必不可少得设备2.19Maintenance维护anyperiodicorunplannedsupportandverificationoperationsdesignedtokeeppremisesandequipmentinproperworkingcondition为了保持房屋和设备处于适宜得工作状态所实施得定期或非筹划得维护和验证检查 2.20manufacturingoperation制造过程setofoperationsfromtheweighingofrawmaterialstothemakingof。
thebulkproduct从原料得称量到散装产品得制造必走得过程2.21out-of-specification超出规格examination,measurementortestresultthatdoesnotcomplywithdefinedacceptancecriteria检查，测量或测试得结果不符合规定得可接收标准2.22packagingoperation包装过程allpackagingstepsincludingfillingandlabelling,whichabulkproducthastoundergoino rdertobecomeafinishedproduct所有包装步骤包括填充，就是散装产品到成品必走得过程2.23packagingmaterial包材anymaterialemployedinthepackagingofacosmeticproduct,excludinganyouterpackagingusedfortransportation任何用于包装产品得包装材料，除了用于运输得外包装NOTEPackagingmaterialsarereferredtoasprimaryorsecondaryaccordingto。
whetherornottheyareintendedtobeindirectcontactwiththeproduct.注意：包材可分为第一和第二材料根据它们是否与产品直接接触2.24Plant工厂locationforproductionofcosmeticproducts化妆品厂得位置 2.25Premises厂房physicallocation,buildingsandsupportingstructuresusedtoconductreceipt,storage,manufacturing,packaging,co ntrolandshipmentofproduct,rawmaterialsandpackagingmaterials-8物理位置，建筑物和支撑结构，用于实施接收，储存，制造，包装，控制和产品，原料，包材运输等活动2.26production生产manufacturingandpackagingoperations制造和包装过程2.27qualityassurance质量保证allthoseplannedandsystematicactivitiesnecessarytoprovideconfidencethataproductsatisfiesgivenacceptancecriteria为了确保产品符合标准所进行得筹划和系统得活动。
2.28rawmaterial原料anysubstancegoinginto 3Word版本。