巴西验厂标准-中英文对照版

巴西验厂标准RESOLUTION-RDCNº17,OF16.04.102010年4月16日RDCNº17决议ProvidesfortheGoodPracticesofMedicamentManufacturing.TheCollegiateDirectorateoftheBrazilianNationalHealthSurveillanceAgency(ANVS),ontheuseoftheattributionsconferedbyart.oftheregulationsapprovedbyDecreeNº3.029,ofApril16,1999,andinviewoftheprovisionsofitemIIand§§1and3ofart.ftheInternalStatutesapproved,asprovidedbyAttachmentIofOrdinanceNo.354ofANVISA,ofAugust11,2006,republishedintheFederalGazetteofAugust21,2006,inmeetingheldonApril12,2010,adoptthefollowingResolutionoftheCollegiateDirectoryandI,Director-President-Surrogate,determineitspublication:药品GMP要求巴西国家卫生监督管理局（ANVS）依据1999年4月16日通过的3029号法令第11条规定，考虑到ANVISA在2006年8月11日通过的并于2006年8月21日在政府公报上重新发布的第354号法令附件一中批准的内部法规第f条第II项和1、3项规定，于2010年4月12日举行会议，通过以下管理局决议，我作为卫生监督管理局局长决定发布此决议：TITLEI标题1INITIALPROVISIONS初步规定CHAPTERI第一章OBJECTIVE目的Art.1ThispurposeofthepresentresolutionistoestablishtheminimumrequirementstobecompliedwithinMedicamentManufacturinginordertostandardizetheverificationofcompliancewiththeGoodPracticesofMedicamentManufacturing(BPF)forhumanuse,duringthesanitarysurveillances.第1条：本决议的目的是规定在药品生产过程中必须满足的最低要求，在卫生监督过程中规范人用药品生产是否符合GMP的核查活动。§1ResolutionGMCNo.15/09-GoodManufacturePracticesofPharmaceuticalProductsandtheMechanismofImplementationwithintheMERCOSULscopeisherebyinternalized,havingestablishedtheadoptionofReportNo.37ofWHO(TechnicalReportSeries908),publishedin2003.综合医学委员会第15/09号决议-“药品GMP和南方共同市场实施机制在此实现内部化，采用世界卫生组织于2003年出版的第37号报告（技术报告908系列）。§2Alternativeactions,otherthanthosedescribehereinmatbeadopted,soastomonitorthetechnologicalprogressortomeetspecificneedsofamedicament,providedthelatterarevalidatedbythemanufacturerandthatthemedicament'squalityisguaranteed.药品生产厂家也可采用本决议没有规定的其它替代措施，以便监控技术进步，满足药品特定需要，但条件是这些措施得到验证，并能保证药品的质量。CHAPTERII第二章SCOPE范围Art.2themedicamentmanufacturingestablishmentsshallcomplywiththeforegoingguidelinesinalltheoperationsinvolvedintheMedicamentManufacturing,includingthemedicamentsunderdevelopmentmeanttoclinicaltests.药品生产场所应当在所涉及的所有操作中符合上述准则，包括研发中的临床试验。Soleparagraph.Theactivitiesrelatedtosubstancessubjecttospecialcontrol,ormedicamentsthatcontainsuchsubstances,shallcomplywiththeprovisionsofspecificlaws,inadditiontotherequirementsprovidedherein.独立条款：对于特殊控制下的物质，或含有这种物质的药物，相关的活动除了符合本文规定外，还应符合具体的法律规定。Art.3theregisteredmedicamentsshallonlybemanufacturedbycompaniesdulylicensedandauthorizedforsuchactivity,whichshallbeinspectedregularlybythecompetentnationalauthorities.第3条：注册的药品只能通过经正式许可和授权从事生产的公司制造，并由国家主管部门定期检查。Art.4Thisresolutiondoesnotcompriseallaspectsofoccupationalsafetyorenvironmentalprotection,whichareregulatedbyspecificlaws.第4条：该决议不包括具体法律规定的职业安全和环保方面。Soleparagraph.Themanufacturershallassuretheemployees'safety,andtakethenecessarymeasurestoprotecttheenvironment.独立条款：生产厂家应保证员工的安全，并采取必要的措施，以保护环境。CHAPTERIII第三章DEFINITIONS定义Art.5Forthepurposeofthisresolution,thefollowingdefinitionsareadopted:第5条：为达到本决议目的，采用以下定义：I-Correctiveaction:Anactioncarriedouttopurgethecauseofadetectednon-conformityoranyotherundesirablesituation;纠正措施：为消除发现的不合格项或其它不良情况而采取的措施;II-Preventiveaction:Anactioncarriedouttopurgethecauseofapotentialnon-conformityoranyotherpotentialundesiredsituation;预防措施：为消除潜在的不合格项或其它潜在不良情况而采取的措施;;III-Adjustment:Anoperationmeanttocausethemeasuringinstrumenttoprovideaperformancecompatiblewithitspurpose;调节：使测量仪器提供与其使用目的相符合性能的操作;IV-Referencesamples:Rawmaterialsandfinishedproductsampleswithheldbythemanufacturer,dulyidentified,foradefinedperiodoftime.Thequantityofasamplemusthaveatleasttwicetheamountnecessarytocarryoutalltheanalysesforeseen;参考样品：由生产商及时标识并在规定期限内留存的原材料和成品样品。样品数量必须至少是两倍全检需要的量;V-Representingsample:Aquantityofsamplecalculatedstatistically,representingthesampleduniverse,takenforthepurposesofassessmentforclearanceofabatchofmaterialorproduct;代表样品：一定数量的经过数量统计而取到的的样品，它对取样来源有代表性，用于在物料或产品批次放行前的质量评估;VI-Prechamber:Enclosedspacewithtwoormoredoors,interposedbetweentwoormoreareasofdistinctclassesofasepsis,withthepurposeofcontrollingtheairflowbetweenbothareas,whenevertheymustbeenteredinto.Theprechamberisdesignedsoastobeusedforpersons,materialsorequipments;前室：位于两个或多个不同无菌级别区域之间的封闭空间，它有两个以上的门，用来控制进出门时区域之间的空气流动，前室为方便人员、物料或设备的进出设计;VII-Area:Limitedphysicalspacewheretheoperationsarecarriedoutunderspecificenvironmentalconditions;区域：在特定环境条件下进行操作的有限物理空间，;VIII-Cleanarea:Anareawithdefinedenvironmentalcontrolintermsofcontaminationbyviableandnonviableparticles,designed,builtandusedsoastoreducetheintroduction,generationandwithholdingofcontaminantinside;洁净区：在活性和非活性微粒污染方面具有特定环境控制的区域，其设计、建造和使用是为了减少污染物的进入、产生和停留;IX-Segregatedarea:Facilitiesthatofferfullinsulationinallaspectsofanoperation,includingpersonnelandequipmentdisplacement,withwell-establishedprocedures,controlsandmonitoring.Itmayincludephysicalbarriers,aswellasseparateairingsystems;however,itdoesnotnecessarilyimplydifferentbuildings;;隔离区：为包括人员和设备移动等各方面操作提供与外界完全隔绝的设施，拥有完善的程序、控制和监测手段。它可包括实际的隔断，以及独立的空调系统，但这并不一定意味着在不同的建筑物中。X-Gaging:Asetofoperationsthatwillestablish,underthespecifiedconditions,arelationbetweenthenumbersindicatedbyameasuringinstrumentorsystem,orthevaluesrepresentedby