墨西哥GMP中英文.docx
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墨西哥GMP中英文.docx
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墨西哥GMP中英文
墨西哥官方标准NOM-164-SSA1-1998,药品良好生产规范(GMP)。
(此段为修订历史,翻译略)
MexicanOfficialStandardNOM-164-SSA1-1998,GoodManufacturingPracticesforpharmaceuticals.MEXICANOFFICIALSTANDARDNOM-164-SSA1-1998,GOODMANUFACTURING
PRACTICESFORDRUGS.
JAVIERCASTELLANOSCoutinho,PresidentoftheNationalAdvisoryCommitteeonHealth
RegulationandDevelopment,basedonArticle39oftheOrganicLawofFederalPublicAdministration;4o.and69-HoftheFederalAdministrativeProcedureAct;3rd.,fractionsXXIIIandXXIV,13,SectionA),fractionII,195,201,210,212andotherappiicableprovisionsoftheGeneralHealthLaw,38,partII,40,sectionsIandV,41,47oftheFederalLawonMetrologyandStandardization,the8th.,9o.,15,fractionV,18and100oftheRegulationsforHealthSupplies,28and34oftheRulesoftheLawFederalMetrologyandStandardizationand7,fractionsVandXIXand23sectionIIoftheInternalRegulationsoftheMinistryofHealth,and
WHEREAS
ThatonOctober19,1998,pursuanttotheprovisionsofArticle46,SectionIoftheFederalLawonMetrologyandStandardization,DGHealthProductssubmittedtotheNationalAdvisoryCommitteeonHealthRegulationandDevelopment,thedraftoftheOfficialMexicanStandard.
ThatonDecember16,1998,pursuanttotheagreementoftheCommitteeandtotheprovisionsofArticle47,SectionIoftheFederalLawonMetrologyandStandardization,waspublishedintheOfficialJournaloftheFederationonthedraftofthisOfficialStatementMexicana,totheeffectthatwithinthenextsixtycalendardaysaftersuchpublication,interestedpartiessubmittheircommentstoNationalAdvisoryCommitteeonHealthRegulationandDevelopment.
WhetherresponsestocommentsreceivedbythesaidCommittee,werepublishedpriortotheissuaneeofthisstandardintheOfficialJournaloftheFederation,underthetermsofArticle47,paragraphIIIoftheFederalLawonMetrologyandStandardization.
Thatinviewoftheforegoing,withtheapprovaloftheNationalAdvisoryCommitteeonHealthRegulationandDevelopment,isissuingthefollowing:
NOM-164-SSA1-1998,GoodManufacturingPracticesforpharmaceuticals.
PREFACE前言
InthepreparationofthisOfficialMexicanNormtookthefollowingadministrativeunitsand
institutions:
下列政府部门和机构参与了本标准指导的编制:
SECRETARYOFHEALTH.
DGHealthSupplies.
LegalAffairsDirectorate.
DEPARTMENTOFTRADEANDINDUSTRIALDEVELOPMENT.
DGMonitoringAnalysisandInternationalTradeAgreements.
DirectorateGeneralofDomesticTradePolicy.
MEXICANPHARMACEUTICALASSOCIATION,B.C.
NATIONALCHAMBEROFINDUSTRYTRANSFORMATION.
Section89.
NATIONALCHAMBEROFTHEPHARMACEUTICALINDUSTRY.
NATIONALASSOCIATIONOFCHEMICALPHARMACEUTICALBIOLOGOSMEXICO,ACINTERAGENCYCOMMISSIONGoodManufacturingPractices.
SOCIALSECURITYMEXICANINSTITUTE.
TechnicalControlUnitInputs.
NATIONALAUTONOMOUSUNIVERSITYOFMEXICO.
FacultyofChemistry.
ZaragozaFacultyofHigherEducation.
INDEX目录
0.introduction介绍
1.Objectiveandscope目标和范围
2.ReferenceS对照品
3.Definitions定义
4.Abbreviations缩略词
5.generalrequirement总体要求
6.staff员工
7.QualityUnit质量部门
8.Productionunit生产部
9.Facilities设备
10.team小组
11.MasterProductionOrde主生产指令
12.Productionby生产
13.BatchFilesanditems批文件和项目
14.Controlproceduresproduction生产控制程序
15.Packagingandlabelingofthedrug^品的包装和贴签
16.Laboratorycontrolsandinspectior实验室控制和检验
17.Homogenates?
昆批匕
18.Recovery,reworkandrework回收,返工和重加工
19.StorageandDistributionControl仓储和分发控制
20.validation验证
21.Returnsandcomplaints退货和投诉
22.Destructionanddisposalofwaste废物销毁和处理
23.ComplianeewithinternationalstandardsandMexican与国际和墨西哥标准相符
24.bibliography参考书目
25.ObservaneeofStandar标准仪式
26.validity有效期
Healthisakeyfactorforsocialdevelopmentandwelfareofthecommunity,soitisuptotheMinistryofHealthtoestablishminimumrequirementsthatmustbemetduringthedrugmanufacturingprocesstoensurethequalityofthem,becausearethebasisforthemanufactureofmedicaments.
健康是社会发展和社会福利的一个关键因素,所以它取决于卫生部在药品生产过程为确保药品的质量建立最低要求且必须满足这些最低要求,因为这是药品生产的基础。
TheGoodManufacturingPracticesthereforerequirecontrolofpersonnel,equipment,facilities,documentation,materials,aswellasallstagesofthemanufacturingprocess.
本药品良好生产规范(GMP)因此要求除了对药品生产的各步骤进行控制外,对人员,设备,设施,文件,物料也一样进行控制。
1.Objectiveandscope目标和范围
1.1.target目标
ThisMexicanOfficialStandardestablishestheminimumrequirementsforgoodmanufacturingpracticesforactivedrug.
本墨西哥官方标准建立了活性药物良好生产规范(GMP)的最低要求。
1.2.Scope范围
ThisStandardismandatoryforestablishmentsengagedinthemanufactureofdrugsoractiveingredients.
本标准对涉及从事生产药物或活性成分的场所(机构)是强制性(必须满足的)。
2.References对照
ForthecorrectapplicationofthisstandardshouldconsultthefollowingMexicanOfficialStandards:
对于这个标准的正确应用应该参考下面的墨西哥官方标准:
2.1.NOM-OO2-SCFI-1993Pre-packagedproductsyardage,tolerancesandverificationmethods.NOM-OO2-SCFI-1993预包装产品码数,公差和检验方法
2.2.NOM-O52-ECOL-1993,whichestablishesthecharacteristicsofhazardouswaste,thelistofthemandthethresholdabovewhichahazardouswastebecauseofitstoxicity.
NOM-O52-ECOL-1993有害废物列表以及不同毒性特征的不同有害废物阈值
2.3.NOM-O73-ECOL-1994,whichestablishesthemaximumpermissiblelimitsofpollutantsinwastewaterdischargestoreceivingbodiesfromthepharmaceuticalandpharmochemical.
NOM-O73-ECOL-1994建立制药和医化排放的废水中污染物的最大允许限度
2.4.NOM-127-SSA1-1994,EnvironmentalHealth.Waterforhumanuseandconsumption.Permissiblelimitsofqualityandmustundergotreatmenttothewatertomakeitdrinkable.
NOM-127-SSA1-1994,环境卫生,人用水,质量允许限度和经常处理使其可饮用
2.5.NOM-O59-SSA1-1993,GoodManufacturingPracticesforchemicalindustryestablishmentsengagedinmanufacturingpharmaceuticaldrugs.
NOM-O59-SSA1-1993化工企业涉及药品生产的良好生产规范。
3.Definitions定义
Forpurposesofthisrule,theterm:
本条令的目的,术语
3.1.Motherliquor,liquidsobtainedfromseparationsmadeforobtainingintermediateproductsandfinishedproductscontainingrecoverableamountsand/orreusableofrawmaterial,intermediateand/orfinishedproduct.
母液,从中间体或成品获取过程中分离出来的包含可回收数量和/或可再用物料,中间体和/或
成品的液体。
32Warehouse,theareawhereyoustorerawmaterials,materials,intermediatesanddrugsundercontrolledconditionsoforderandcleaniiness.
仓库,在受指令和清洁程度控制的用于储存原料,物料,中间体和成品的地方
3.3.GoodManufacturingPractice,thesetofguidelinesandmonitoringactivitiesrelatedtopersonnel,equipment,facilities,documentation,materials,andallstagesofthemanufacturingprocesstoensurethatdrugsdevelopedtocomplywiththespecifications.
良好生产规范(GMP),是和人员,设备,设施,文件,物料以及生产过程的所有步骤相关的为保证药品发展最终符合它的质量标准的一套指导和监测活动。
3.4.Calibrationtodetermineasetofoperationsunderspecificconditions,therelationshipbetweenthevaluesindicatedbyaninstrument,themeasurementsystem,representedbyameasurementequipmentandknownvaluestoarefereneestandard.
校验是在特定的条件下,决定一个仪器和测量系统显示的数值之间的关系的一套操作,由测量设备和参考标准的已知值表示。
3.5.Quality,complianeewithspecificationsestablishedtoensurefitnessforuse.
质量,符合已建立的质量标准以保证适用。
3.6.Component,allthesubstancesinvoIvedinthevariousstagesofmanufacturethedrug.
元件,构件(这里暂翻成物料),药品生产各阶段中涉及的所有物质。
3.7.Contamination,preseneeofphysicalentities,chemicalorbiologicalundesirable.
污染,不被需要的物理,化学或生物实体的存在。
3.8.Cross-contamination,thepreseneeofphysicalentities,chemicalorbiologicalundesirablefromothermanufacturingprocesses.
交叉污染,从其他生产工艺中来的不被需要的物理,化学或生物实体的存在。
3.9.Processcontrol,themonitoringisperformedintheprocessinordertoinsurethatthespecificationisoccurring.
工艺控制,工艺中为保证达到标准而进行的监测。
3.10.Post-harvest,theproductrecoveredfromthemotherliquor.
收获后(暂翻译为后产品',从母液中回收的产品。
3.11.Specification,thedescriptionofamaterial,substaneeorproduct,includingqualityparameters,acceptancelimitsandtherefereneemethodsusedforitsdetermination.
质量标准,关于一个物料,物质或产品的描述,其中包含质量参数,可接受标准和用于用于检测的参考方法。
3.12.Criticalstagetotheproductionstagetobeespeciallycontrolledtoensurethattheintermediateorfinishedproductmeetsyourspecifications.
生产过程的关键步需要进行特殊控制以保证中间体和成品符合质量标准。
3.13.Drug,allnaturalsubstanee,syntheticorbiotechnologicalthathassomepharmacologicalactivity,andisidentifiedbyitsphysical,chemicalorbiologicalactions,whicharenotpresentedinadosageformthatiseligibletobeusedasadrugoringredientadrug.
药品,所有具有一定的药理活性,并确定了它的物理,化学或生物作用的自然的,合成的或生物技术物质,不限定表现为被用作药物或成分药物的剂型。
3.14.Expirydatetothedateshownintheprimarypackagingmaterialand/orsecondaryanddeterminestheusefullifeofthedrug,isestablishedfromthedateofmanufacture,basedonstabilitystudies.
有效期为显示在第一包装材料和/或第二包装材料上的用来表示药品的使用寿命的日期,建立在稳定性研究的基础上,取决于生产日期。
3.15.Dateofrevaluation,atthedatebeforewhichanintermediateorfinishedproductmeetsallspecificationsandbeyondwhichtheintermediateorfinishedproductcannotbeusedwithoutareassessment.
复验期,在此日期前,一个中间产品或成品符合所有质量标准,而在此日期后,该中间产品或成品在未经过重新评估不能使用。
3.16.Lot,thespecificamountofanyrawmaterialorinput,whichismanufacturedinaproductioncycleonequivalenttermsofoperationandduringagivenperiod.
批,在规定时期内经过系列等同的操作生产循环生产出来的规定数量的原料或投入料。
3.17.Rawmaterial,thesubstaneefromanysourcethatisusedforthemanufactureofdrugsornaturalorsyntheticdrugs.
原料,从某些来源得来的用于药品或自然或合成药品的生产的物质。
3.18.Showstheamountofmaterialwhosecompositionisrepresentativeofthelottobeexamined.
显示物料的数量,而该物料的成分是代表要被检验的该批
3.19.Lotnumber,thealphanumericcombin
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