21CFR210211cGMP中英对照版同名6532.docx

21CFR210211cGMP中英对照版同名6532.docx

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21CFR210211cGMP中英对照版同名6532

21CodeofFederalRegulationsParts

210and211

Part210

-CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PROCESSING,PACKING,ORHOLDINGOFDRUGS;GENERAL

PART211 

-CURRENTGOODMANUFACTURINGPRACTICEFORFINISHEDPHARMACEUTICALS

210部分—人用及兽用药品的生产、加工、包装或贮存的CGMP（概述）

211部分—制剂药品的CGMP

Part210-CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PROCESSING,PACKING,ORHOLDINGOFDRUGS;GENERAL

210.1Statusofcurrentgoodmanufacturingpracticeregulations.

210.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.

210.3Definitions.

AUTHORITY:

Secs.201,501,502,505,506,507,512,701,704oftheFederalFood,Drug,andCosmeticAct（21U.S.C.321,351,352,355,356,357,360b,371,374）.

SOURCE:

43FR45076,Sept.29,1978,unlessotherwisenoted.

§210.1Statusofcurrentgoodmanufacturingpracticeregulations.

（a）TheregulationssetforthinthispartandinParts211through226ofthischaptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorcontrolstobeusedfor,themanufacture,processing,packing,orholdingofadrugtoassurethatsuchdrugmeetstherequirementsoftheactastosafety,andhastheidentityandstrengthandmeetsthequalityandpuritycharacteristicsthatitpurportsorisrepresentedtopossess.

（b）ThefailuretocomplywithanyregulationsetforthinthispartandinParts211through226ofthischapterinthemanufacture,processing,packing,orholdingofadrugshallrendersuchdrugtobeadulteratedundersection501（a）

（2）（B）oftheactandsuchdrug,aswellasthepersonwhoisresponsibleforthefailuretocomply,shallbesubjecttoregulatoryaction.

§210.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.

（a）TheregulationsinthispartandinParts211through226ofthischapterastheymaypertaintoadrugandinParts600through680ofthischapterastheymaypertaintoabiologicalproductforhumanuse,shallbeconsideredtosupplement,notsupersede,eachother,unlesstheregulationsexplicitlyprovideotherwise.Intheeventthatitisimpossibletocomplywithallapplicableregulationsintheseparts,theregulationsspecificallyapplicabletothedruginquestionshallsupersedethemoregeneral.

（b）IfapersonengagesinonlysomeoperationssubjecttotheregulationsinthispartandinParts211through226andParts600through680ofthischapter,andnotinothers,thatpersonneedonlycomplywiththoseregulationsapplicabletotheoperationsinwhichheorsheisengaged.

§210.3Definitions.

（a）Thedefinitionsandinterpretationscontainedinsection201oftheactshallbeapplicabletosuchtermswhenusedinthispartandinParts211through226ofthischapter.

（b）ThefollowingdefinitionsoftermsapplytothispartandtoParts211through226ofthischapter.

（1）ActmeanstheFederalFood,Drug,andCosmeticAct,asamended（21U.S.C.301etseq.）.

（2）Batchmeansaspecificquantityofadrugorothermaterialthatisintendedtohaveuniformcharacterandquality,withinspecifiedlimits,andisproducedaccordingtoasinglemanufacturingorderduringthesamecycleofmanufacture.

（3）Componentmeansanyingredientintendedforuseinthemanufactureofadrugproduct,includingthosethatmaynotappearinsuchdrugproduct.

（4）Drugproductmeansafinisheddosageform,forexample,tablet,capsule,solution,etc.,thatcontainsanactivedrugingredientgenerally,butnotnecessarily,inassociationwithinactiveingredients.Thetermalsoincludesafinisheddosageformthatdoesnotcontainanactiveingredientbutisintendedtobeusedasaplacebo.

（5）Fibermeansanyparticulatecontaminantwithalengthatleastthreetimesgreaterthanitswidth.

（6）Non-fiber-releasingfiltermeansanyfilter,whichafteranyappropriatepretreatmentsuchaswashingorflushing,willnotreleasefibersintothecomponentordrugproductthatisbeingfiltered.Allfilterscomposedofasbestosaredeemedtobefiber-releasingfilters.

（7）Activeingredientmeansanycomponentthatisintendedtofurnishpharmacologicalactivityorotherdirecteffectinthediagnosis,cure,mitigation,treatment,orpreventionofdisease,ortoaffectthestructureoranyfunctionofthebodyofmanorotheranimals.Thetermincludesthosecomponentsthatmayundergochemicalchangeinthemanufactureofthedrugproductandbepresentinthedrugproductinamodifiedformintendedtofurnishthespecifiedactivityoreffect.

（8）Inactiveingredientmeansanycomponentotherthanan``activeingredient.''

（9）In-processmaterialmeansanymaterialfabricated,compounded,blended,orderivedbychemicalreactionthatisproducedfor,andusedin,thepreparationofthedrugproduct.

（10）Lotmeansabatch,oraspecificidentifiedportionofabatch,havinguniformcharacterandqualitywithinspecifiedlimits;or,inthecaseofadrugproductproducedbycontinuousprocess,itisaspecificidentifiedamountproducedinaunitoftimeorquantityinamannerthatassuresitshavinguniformcharacterandqualitywithinspecifiedlimits.

（11）Lotnumber,controlnumber,orbatchnumbermeansanydistinctivecombinationofletters,numbers,orsymbols,oranycombinationofthem,fromwhichthecompletehistoryofthemanufacture,processing,packing,holding,anddistributionofabatchorlotofdrugproductorothermaterialcanbedetermined.

（12）Manufacture,processing,packing,orholdingofadrugproductincludespackagingandlabelingoperations,testing,andqualitycontrolofdrugproducts.

（13）ThetermmedicatedfeedmeansanyTypeBorTypeCmedicatedfeedasdefinedin558.3ofthischapter.Thefeedcontainsoneormoredrugsasdefinedinsection201（g）oftheact.ThemanufactureofmedicatedfeedsissubjecttotherequirementsofPart225ofthischapter.

（14）ThetermmedicatedpremixmeansaTypeAmedicatedarticleasdefinedin558.3ofthischapter.Thearticlecontainsoneormoredrugsasdefinedinsection201（g）oftheact.ThemanufactureofmedicatedpremixesissubjecttotherequirementsofPart226ofthischapter.

（15）Qualitycontrolunitmeansanypersonororganizationalelementdesignatedbythefirmtoberesponsibleforthedutiesrelatingtoqualitycontrol.

（16）Strengthmeans:

（I）Theconcentrationofthedrugsubstance（forexample,weight/weight,weight/volume,orunitdose/volumebasis）,and/or

（ii）Thepotency,thatis,thetherapeuticactivityofthedrugproductasindicatedbyappropriatelaboratorytestsorbyadequatelydevelopedandcontrolledclinicaldata（expressed,forexample,intermsofunitsbyreferencetoastandard）.

（17）Theoreticalyieldmeansthequantitythatwouldbeproducedatanyappropriatephaseofmanufacture,processing,orpackingofaparticulardrugproduct,baseduponthequantityofcomponentstobeused,intheabsenceofanylossorerrorinactualproduction

（18）Actualyieldmeansthequantitythatisactuallyproducedatanyappropriatephaseofmanufacture,processing,orpackingofaparticulardrugproduct.

（19）Percentageoftheoreticalyieldmeanstheratiooftheactualyield（atanyappropriatephaseofmanufacture,processing,orpackingofaparticulardrugproduct）tothetheoreticalyield（atthesamephase）,statedasapercentage.

（20）Acceptancecriteriameanstheproductspecificationsandacceptance/rejectioncriteria,suchasacceptablequalitylevelandunacceptablequalitylevel,withanassociatedsamplingplan,thatarenecessaryformakingadecisiontoacceptorrejectalotorbatch（oranyotherconvenientsubgroupsofmanufacturedunits）.

（21）Representativesamplemeansasamplethatconsistsofanumberofunitsthataredrawnbasedonrationalcriteriasuchasrandomsamplingandintendedtoassurethatthesampleaccuratelyportraysthematerialbeingsampled.

（22）Gang-printedlabelingmeanslabelingderivedfromasheetofmaterialonwhichmorethanoneitemoflabelingisprinted.

[43FR45076,Sept.29,1978,asamendedat51FR7389,Mar.3,1986;58FR41353,Aug.3,1993]

EFFECTIVEDATENOTE:

At58FR41353,Aug.8,1993,210.3wasamendedbyaddingparagraph（b）（22）effectiveAug.3,1994.

Part211-CURRENTGOODMANUFACTURINGPRACTICEFORFINISHEDPHARMACEUTICALS

（21CFRPart211AsofApril,1996）

Authority:

Secs.201,501,502,505,506,507,512,701,704oftheFederalFood,Drug,andCosmeticAct（21U.S.C.321,351,352,355,356,357,360b,371,374）.

Source:

43FR45077,Sept.29,1978,unlessotherwisenoted.

SubpartA--GeneralProvisions

§211.1-Scope.

§211.3-Definitions.

SubpartB--OrganizationandPersonnel

§211.22-Responsibilitiesofqualitycontrolunit.

§211.25-Personnelqualifications.

§211.28-Personnelresponsibilities.

§211.34-Consultants.

SubpartC--BuildingsandFacilities

§211.42-Designandconstructionfeatures.

§211.44-Lighting.

§211.46-Ventilation,airfiltration,airheatingandcooling.

§211.48-Plumbing.

§211.50-Sewageandrefuse.

§211.52-Washingandtoiletfacilities.

§211.56-Sanitation.

§211.58-Maintenance.

SubpartD--Equipment

§211.63-Equipmentdesign,size,andlocation.

§211.65-Equipmentconstruction.

§211.67-Equipmentcleaningandmaintenance.

§211.68-Automatic,mechanical,andelectronicequipment.   

§211.72-Filters.

SubpartE--ControlofComponentsandDrugProductContainersandClosures

§211.80-Generalrequirements.

§211.82-Receiptandstorageofuntestedcomponents,drugproductcontainers,andclosures.

§211.84-Testingandapprovalorrejectionofcomponents,drugproductcontainers,andclosures.

§211.86-Useofapprovedcomponents,drugproductcontainers,andclosures.

§211.87-Retestingofapprov