21CFR210211cGMP中英对照版同名6532Word格式文档下载.docx
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21CFR210211cGMP中英对照版同名6532Word格式文档下载.docx
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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
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