美国FDACGMP英汉对照版.docx
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美国FDACGMP英汉对照版
美国FDACGMP英汉对照版
SubpartA-GeneralProvisions
§211.1Scope
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.
§211.3Definitions.
Thedefinitionssetforthin§210.3ofthischapterapplyinthispart.
A．总则
211．1范围
（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP）。
（b）在本章里的这些针对药品的现行GMP条例和本章600～680部分的所有针对人用生物制品的现行GMP条例，除非明确另有说明外，应认为是对本部分条例的补充，而不是代替。
本章其他部分或本章600～680g各部分均可适用的条例，前部分的条例可以代替本部分条例。
（c）在考虑经提议的，发表在1978年9月29日联邦注册表（FR）上一项免除时，若产品及其所有成分是以人用物品形式作一般销售和消费，且这些产品根据其预期用途，亦可列入药品的范围，则不应对这些非处方药（OTC）实施本部分条例，直至进一步的通知为止。
本章110部分和113至119部分的条例用于鉴别这些亦是食品的OTC药品是否按照GMP的要求生产、加工、包装＆贮存。
211．3定义
本章211．3中的定义使用于本部分。
goodmanufacturingpractice（GMP）良好的生产管理规范
over-the-counter（OTC）人用非处方药
per`tain适合，属于expli`citly明白地，确切地
super`sede代替，取代，延期ex`emption解除，免除，免税
SubpartB-OrganizationandPersonnel
§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.
B组织与人员
211．22质量控制部门的指责
（a）本部门有批准和拒收所有成分、药品包装容器、密封件、中间体、包装材料、标签及药品的职责与权力。
复查生产记录的权力，保证不产生差错，或若发生差错，保证他们充分调查这些差错。
本部门负责根据合同，批准或拒收由其他公司生产、加工、包装或贮存的药品。
（b）适当的实验室检验设备、批准（或拒收）的各种成分、药品容器、密封件、包装材料及药品，质量控制部门室可以获得的。
（c）本部门由批准或驳回影响药品的均一性、效价或含量、质量及纯度的所有程序或规格标准的职责。
（d）适用于本部门的职责与程序，应成文字材料，并应遵循。
Au`thority权威，威信，权力，授权
closure关闭，使终止，密封件
in-processmaterials中间体
§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.
211．25人员资格
a）每位从事药品生产、加工、包装或仓贮工作的人员，应接受培训、教育及有实践经验，完成委派的各项职务。
培训是按照现行GMP（包括本章的现行GMP条例和这些条例要求的成文程序）中涉及雇员的内容。
邀请合格人员指导，并连续多次培训，保证雇员熟悉现行GMP（CGMP）对他们的要求。
b）负责监督药品的生产、加工、包装或仓贮工作的每一个人员，应受过教育、培训及有经验，完成委派的各项职务。
以此作为提供药品具有安全性、均一性、效价或含量、质量及纯度的保证。
c）有足够量执行和监督每种药品的生产、加工、包装或仓贮的合格人员。
thereof在其中，关于…的，相关地
currentgoodmanufacturingpractice（CGMP）现行GMP
supervise监督，管理，指导
purports声称.
§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.
§211.34Consultants.
Consultantsadvisingonthemanufacture,processing,packing,orholdingofdrugproductsshallhavesufficienteducation,training,andexperience,oranycombinationthereof,toadviseonthesubjectforwhichtheyareretained.Recordsshallbemaintainedstatingthename,address,andqualificationsofanyconsultantsandthetypeofservicetheyprovide.
211．28人员职责
a）从事药品生产、加工、包装或仓贮的人员，应穿着适合于其履行职责的清洁衣服，按需要，按头部、脸部、手部、臂部加外罩，防止药品受污染。
b）人员保持良好的个人卫生和健康。
c）未经监督人员允许，其他人不能进入限制入内的建筑物和设施。
d）任何人,在任何时间,明显表现出带有影响药品安全性和质量的疾病或开放性损伤,应避免接触各种成分、药品容器、包装设备、密封件、中间体,直至病愈或经医学鉴定认为对药品安全性及质量无危害性为止．教育所有人员,报告监督人员对药品有不利影响的健康情况．
211.34顾问
为了对问题提出意见,应聘请顾问对药品生产、加工、包装或仓贮提出建议,他们受过足够的教育,培训,且有丰富的实践经验,保留他们的姓名、地址、任何的顾问资格及服务形式等履历资料.
Protectiveapparel洁净服，保护服
sanitation卫生，卫生设施，
jeopardize危害
SubpartC-BuildingsandFacilities
§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）Quarantinestoragebeforerelea
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