CRF 21 Part 111 膳食补充剂GMP规范中英文对照VIP专享VIP免费

[CodeofFederalRegulations][Title21,Volume2][RevisedasofApril1,2015][CITE:21CFR111]TITLE21--FOODANDDRUGSCHAPTERI--FOODANDDRUGADMINISTRATIONDEPARTMENTOFHEALTHANDHUMANSERVICESSUBCHAPTERB--FOODFORHUMANCONSUMPTIONPART111CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PACKAGING,LABELING,ORHOLDINGOPERATIONSFORDIETARYSUPPLEMENTS第111部分饮食添加剂生产、包装、标签和储藏操作的CGMP规范SubpartA--GeneralProvisions一般规定Sec.111.1Whoissubjecttothispart?这部分的主要内容是什么？(a)Exceptasprovidedbyparagraph(b)ofthissection,youaresubjecttothispartifyoumanufacture,package,label,orholdadietarysupplement,including:除了b节中规定的以外，生产、包装、贴标或保存膳食补充剂都受到这个规范的支配，包括：(1)Adietarysupplementyoumanufacturebutthatispackagedorlabeledbyanotherperson;and一个生产商生产的膳食补充剂，却由另一个进行包装或贴标；(2)AdietarysupplementimportedorofferedforimportinanyStateorterritoryoftheUnitedStates,theDistrictofColumbia,ortheCommonwealthofPuertoRico.出口到任何国家或美国地区，哥伦比亚特区，或波多黎各自由邦的膳食补充剂(b)Therequirementspertainingtoholdingdietarysupplementsdonotapplytoyouifyouareholdingthosedietarysupplementsataretailestablishmentforthesolepurposeofdirectretailsaletoindividualconsumers.Aretailestablishmentdoesnotincludeawarehouseorotherstoragefacilityforaretailerorawarehouseorotherstoragefacilitythatsellsdirectlytoindividualconsumers.若这些膳食补充剂在零售店唯一的目的是零售给个人消费者，则控制膳食补充剂的有关需求不适用。零售店不包括零售商的仓库或其他存储设施，或直接销售给个人消费者的仓库或其他存储设施。Sec.111.3Whatdefinitionsapplytothispart?如何定义这部分？Thedefinitionsandinterpretationsoftermsinsection201oftheFederalFood,Drug,andCosmeticAct(theact)applytosuchtermswhenusedinthispart.Forthepurposeofthispart,thefollowingdefinitionsalsoapply:联邦食品、药品和化妆品法案（该法案）第201节中的定义和术语解释适用于此部分所用到的术语。基于此部分的目的，下面的定义同样适用：Actualyieldmeansthequantitythatisactuallyproducedatanyappropriatestepofmanufactureorpackagingofaparticulardietarysupplement.实际产量是指在一个独有的膳食补充剂生产、加工、包装的任何适当步骤所产生的实际数量。Batchmeansaspecificquantityofadietarysupplementthatisuniform,thatisintendedtomeetspecificationsforidentity,purity,strength,andcomposition,andthatisproducedduringaspecifiedtimeperiodaccordingtoasinglemanufacturingrecordduringthesamecycleofmanufacture.批是指在规定限度内具有同一性质和质量,并在同一连续生产周期中生产出来的一定数量的膳食补充剂。Batchnumber,lotnumber,orcontrolnumbermeansanydistinctivegroupofletters,numbers,orsymbols,oranycombinationofthem,fromwhichthecompletehistoryofthemanufacturing,packaging,labeling,and/orholdingofabatchorlotofdietarysupplementscanbedetermined.用于识别“批”的一组数字或字母加数字。用以追溯和审查该批药品的生产历史。Componentmeansanysubstanceintendedforuseinthemanufactureofadietarysupplement,includingthosethatmaynotappearinthefinishedbatchofthedietarysupplement.Componentincludesdietaryingredients(asdescribedinsection201(ff)oftheact)andotheringredients.组分是指用于膳食补充剂生产的相关成分，包括在最终成品中不出现的物质。组分包括膳食成分（如法案201节中所述的营养成分和另外的成分）。Contactsurfacemeansanysurfacethatcontactsacomponentordietarysupplement,andthosesurfacesfromwhichdrainageontothecomponentordietarysupplement,orontosurfacesthatcontactthecomponentordietarysupplement,occ...