美国现行药品生产质量管理规范cGMPen.docx
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美国现行药品生产质量管理规范cGMPen.docx
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美国现行药品生产质量管理规范cGMPen
[CodeofFederalRegulations]
[Title21,Volume4]
[RevisedasofApril1,2004]
[CITE:
21CFR211]
TITLE21--FOODANDDRUGS
SUBCHAPTERC-DRUGS:
GENERAL
PART211
CURRENTGOODMANUFACTURINGPRACTICEFORFINISHEDPHARMACEUTICALS
SubpartA--GeneralProvisions
Sec.211.1Scope.
Linktoanamendmentpublishedat69FR29828,May25,2004.
(a)Theregulationsinthispartcontaintheminimumcurrentgoodmanufacturingpracticeforpreparationofdrugproductsforadministrationtohumansoranimals.
(b)Thecurrentgoodmanufacturingpracticeregulationsinthischapter,astheypertaintodrugproducts,andinparts600through680ofthischapter,astheypertaintobiologicalproductsforhumanuse,shallbeconsideredtosupplement,notsupersede,theregulationsinthispartunlesstheregulationsexplicitlyprovideotherwise.Intheeventitisimpossibletocomplywithapplicableregulationsbothinthispartandinotherpartsofthischapterorinparts600through680ofthischapter,theregulationspecificallyapplicabletothedrugproductinquestionshallsupersedetheregulationinthispart.
(c)Pendingconsiderationofaproposedexemption,publishedintheFederalRegisterofSeptember29,1978,therequirementsinthispartshallnotbeenforcedforOTCdrugproductsiftheproductsandalltheiringredientsareordinarilymarketedandconsumedashumanfoods,andwhichproductsmayalsofallwithinthelegaldefinitionofdrugsbyvirtueoftheirintendeduse.Therefore,untilfurthernotice,regulationsunderpart110ofthischapter,andwhereapplicable,parts113to129ofthischapter,shallbeappliedindeterminingwhethertheseOTCdrugproductsthatarealsofoodsaremanufactured,processed,packed,orheldundercurrentgoodmanufacturingpractice.
[43FR45077,Sept.29,1978,asamendedat62FR66522,Dec.19,1997]
EffectiveDateNote:
At69FR29828,May25,2004,§211.1wasamendedbyrevisingparagraph(b),effectiveMay25,2005.Fortheconvenienceoftheusertherevisedtextfollows:
Sec.211.3Definitions.
Thedefinitionssetforthin§210.3ofthischapterapplyinthispart.
SubpartB--OrganizationandPersonnel
Sec.211.22Responsibilitiesofqualitycontrolunit.
(a)Thereshallbeaqualitycontrolunitthatshallhavetheresponsibilityandauthoritytoapproveorrejectallcomponents,drugproductcontainers,closures,in-processmaterials,packagingmaterial,labeling,anddrugproducts,andtheauthoritytoreviewproductionrecordstoassurethatnoerrorshaveoccurredor,iferrorshaveoccurred,thattheyhavebeenfullyinvestigated.Thequalitycontrolunitshallberesponsibleforapprovingorrejectingdrugproductsmanufactured,processed,packed,orheldundercontractbyanothercompany.
(b)Adequatelaboratoryfacilitiesforthetestingandapproval(orrejection)ofcomponents,drugproductcontainers,closures,packagingmaterials,in-processmaterials,anddrugproductsshallbeavailabletothequalitycontrolunit.
(c)Thequalitycontrolunitshallhavetheresponsibilityforapprovingorrejectingallproceduresorspecificationsimpactingontheidentity,strength,quality,andpurityofthedrugproduct.
(d)Theresponsibilitiesandproceduresapplicabletothequalitycontrolunitshallbeinwriting;suchwrittenproceduresshallbefollowed.
Sec.211.25Personnelqualifications.
(a)Eachpersonengagedinthemanufacture,processing,packing,orholdingofadrugproductshallhaveeducation,training,andexperience,oranycombinationthereof,toenablethatpersontoperformtheassignedfunctions.Trainingshallbeintheparticularoperationsthattheemployeeperformsandincurrentgoodmanufacturingpractice(includingthecurrentgoodmanufacturingpracticeregulationsinthischapterandwrittenproceduresrequiredbytheseregulations)astheyrelatetotheemployee`sfunctions.TrainingincurrentgoodmanufacturingpracticeshallbeconductedbyqualifiedindividualsonacontinuingbasisandwithsufficientfrequencytoassurethatemployeesremainfamiliarwithCGMPrequirementsapplicabletothem.
(b)Eachpersonresponsibleforsupervisingthemanufacture,processing,packing,orholdingofadrugproductshallhavetheeducation,training,andexperience,oranycombinationthereof,toperformassignedfunctionsinsuchamannerastoprovideassurancethatthedrugproducthasthesafety,identity,strength,quality,andpuritythatitpurportsorisrepresentedtopossess.
(c)Thereshallbeanadequatenumberofqualifiedpersonneltoperformandsupervisethemanufacture,processing,packing,orholdingofeachdrugproduct.
Sec.211.28Personnelresponsibilities.
(a)Personnelengagedinthemanufacture,processing,packing,orholdingofadrugproductshallwearcleanclothingappropriateforthedutiestheyperform.Protectiveapparel,suchashead,face,hand,andarmcoverings,shallbewornasnecessarytoprotectdrugproductsfromcontamination.
(b)Personnelshallpracticegoodsanitationandhealthhabits.
(c)Onlypersonnelauthorizedbysupervisorypersonnelshallenterthoseareasofthebuildingsandfacilitiesdesignatedaslimited-accessareas.
(d)Anypersonshownatanytime(eitherbymedicalexaminationorsupervisoryobservation)tohaveanapparentillnessoropenlesionsthatmayadverselyaffectthesafetyorqualityofdrugproductsshallbeexcludedfromdirectcontactwithcomponents,drugproductcontainers,closures,in-processmaterials,anddrugproductsuntiltheconditioniscorrectedordeterminedbycompetentmedicalpersonnelnottojeopardizethesafetyorqualityofdrugproducts.Allpersonnelshallbeinstructedtoreporttosupervisorypersonnelanyhealthconditionsthatmayhaveanadverseeffectondrugproducts.
Sec.211.34Consultants.
Consultantsadvisingonthemanufacture,processing,packing,orholdingofdrugproductsshallhavesufficienteducation,training,andexperience,oranycombinationthereof,toadviseonthesubjectforwhichtheyareretained.Recordsshallbemaintainedstatingthename,address,andqualificationsofanyconsultantsandthetypeofservicetheyprovide.
SubpartC--BuildingsandFacilities
Sec.211.42Designandconstructionfeatures.
(a)Anybuildingorbuildingsusedinthemanufacture,processing,packing,orholdingofadrugproductshallbeofsuitablesize,constructionandlocationtofacilitatecleaning,maintenance,andproperoperations.
(b)Anysuchbuildingshallhaveadequatespacefortheorderlyplacementofequipmentandmaterialstopreventmixupsbetweendifferentcomponents,drugproductcontainers,closures,labeling,in-processmaterials,ordrugproducts,andtopreventcontamination.Theflowofcomponents,drugproductcontainers,closures,labeling,in-processmaterials,anddrugproductsthroughthebuildingorbuildingsshallbedesignedtopreventcontamination.
(c)Operationsshallbeperformedwithinspecificallydefinedareasofadequatesize.Thereshallbeseparateordefinedareasorsuchothercontrolsystemsforthefirm`soperationsasarenecessarytopreventcontaminationormixupsduringthecourseofthefollowingprocedures:
(1)Receipt,identification,storage,andwithholdingfromuseofcomponents,drugproductcontainers,closures,andlabeling,pendingtheappropriatesampling,testing,orexaminationbythequalitycontrolunitbeforereleaseformanufacturingorpackaging;
(2)Holdingrejectedcomponents,drugproductcontainers,closures,andlabelingbeforedisposition;
(3)Storageofreleasedcomponents,drugproductcontainers,closures,andlabeling;
(4)Storageofin-processmaterials;
(5)Manufacturingandprocessingoperations;
(6)Packagingandlabelingoperations;
(7)Quarantinestoragebeforereleaseofdrugproducts;
(8)Storageofdrugproductsafterrelease;
(9)Controlandlaboratoryoperations;
(10)Asepticprocessing,whichincludesasappropriate:
(i)Floors,walls,andceilingsofsmooth,hardsurfacesthatareeasilycleanable;
(ii)Temperatureandhumiditycontrols;
(iii)Anairsupplyfilteredthroughhigh-efficiencyparticulateairfiltersunderpositivepressure,regardlessofwhetherflowislaminarornonlaminar;
(iv)Asystemformonitoringenvironmentalconditions;
(v)Asystemforcleaninganddisinfectingtheroomandequipmenttoproduceasepticconditions;
(vi)Asystemformaintaininganyequipmentusedtocontroltheasepticconditions.
(d)Operationsrelatingtothemanufacture,processing,andpackingofpenicillinshallbeperformedinfacilitiesseparatefromthoseusedforotherdrugproductsforhumanuse.
[43FR45077,Sept.29,1978,asamendedat60FR4091,Jan.20,1995]
Sec.211.44Lighting.
Adequatelightingshallbeprovidedinallareas.
Sec.211.46Ventilation,airfiltration,airheatingandcooling.
(a)Adequateventilationshallbeprovided.
(b)Equipmentforadequatecontroloverairpressure,micro-organisms,dust,humidity,andtemperatureshallbeprovidedwhenappropriateforthemanufacture,processing,packing,orholdingofadrugproduct.
(c)Airfiltrationsystems,includingprefiltersandparticulatematterairfilters,shallbeusedwhenappropriateonairsuppliestoproductionareas.Ifairisrecirculatedtoproductionareas,measuresshallbetakentocontrolrecirculationofdustfromproduction.Inareaswhereaircontaminationoccursduringproduction,thereshallbeadequateexhaustsystemsorothersystemsadequatetocontrolcontaminants.
(d)Air-handlingsystemsforthemanufacture,processing,andpackingofpenicillinshallbecompletelyseparatefromthoseforotherdrugproductsforhumanuse.
Sec
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