21 Code of Federal Regulations.docx
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21 Code of Federal Regulations.docx
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21CodeofFederalRegulations
21CodeofFederalRegulations
Parts210and211
Part210-CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PROCESSING,PACKING,ORHOLDINGOFDRUGS;GENERALPart211-CURRENTGOODMANUFACTURINGPRACTICEFORFINISHEDPHARMACEUTICALS
Part210-CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PROCESSING,PACKING,ORHOLDINGOFDRUGS;GENERAL
Sec.
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.
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210.1Statusofcurrentgoodmanufacturingpracticeregulations.
(a)TheregulationssetforthinthispartandinParts211through226ofthischaptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorcontrolstobeusedfor,themanufacture,processing,packing,orholdingofadrugtoassurethatsuchdrugmeetstherequirementsoftheactastosafety,andhastheidentityandstrengthandmeetsthequalityandpuritycharacteristicsthatitpurportsorisrepresentedtopossess.
(b)ThefailuretocomplywithanyregulationsetforthinthispartandinParts211through226ofthischapterinthemanufacture,processing,packing,orholdingofadrugshallrendersuchdrugtobeadulteratedundersection501(a)
(2)(B)oftheactandsuchdrug,aswellasthepersonwhoisresponsibleforthefailuretocomply,shallbesubjecttoregulatoryaction.
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210.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.
(a)TheregulationsinthispartandinParts211through226ofthischapterastheymaypertaintoadrugandinParts600through680ofthischapterastheymaypertaintoabiologicalproductforhumanuse,shallbeconsideredtosupplement,notsupersede,eachother,unlesstheregulationsexplicitlyprovideotherwise.Intheeventthatitisimpossibletocomplywithallapplicableregulationsintheseparts,theregulationsspecificallyapplicabletothedruginquestionshallsupersedethemoregeneral.
(b)IfapersonengagesinonlysomeoperationssubjecttotheregulationsinthispartandinParts211through226andParts600through680ofthischapter,andnotinothers,thatpersonneedonlycomplywiththoseregulationsapplicabletotheoperationsinwhichheorsheisengaged.
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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.
PART211-CURRENTGOODMANUFACTURINGPRACTICEFORFINISHEDPHARMACEUTICALS
SubpartA-GeneralProvisions
Sec.
211.1Scope
211.3Definitions
SubpartB-OrganizationandPersonnel
211.22Responsibilitiesofqualitycontrolunit.
211.25PersonnelQualifications.
211.28Personnelresponsibilities.
211.34Consultants.
SubpartC-BuildingsandFacilities
211.42Designandconstructionfeatures.
211.44Lighting.
211.46Ventilation,airfiltration,airheatingandcooling.
211.48Plumbing.
211.50Sewageandrefuse.
211.52Washingandtoiletfacilities.
211.56Sanitation.
211.58Maintenance
SubpartD-Equipment
211.63Equipmentdesign,size,andlocation.
211.65Equipmentconstruction.
211.67Equipmentcleaningandmaintenance.
211.68Automatic,mechanical,andelectronicequipment.
211.72Filters.
SubpartE-ControlofComponentsandDrugProductContainersandClosures
211.80Generalrequirements.
211.82Receiptandstorageofuntestedcomponents,drugproductcontainers,andclosures.
211.84Testingandapprovalorrejectionofcomponents,drugproductcontainers,andclosures.
211.86Useofapprovedcomponents,drugproductcontainers,andclosures.
211.87Retestingofapprovedcomponents,drugproductcontainersandclosures.
211.
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