ICHQ7中英文.docx
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ICHQ7中英文
INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE
ICHHARMONISEDTRIPARTITEGUIDELINE
GOODMANUFACTURINGPRACTICEGUIDEFORACTIVEPHARMACEUTICALINGREDIENTS
Q7
CurrentStep4version
dated10November2000
ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.
中英文对照
Q7
DocumentHistory
FirstCodification
History
Date
NewCodification
November2005
Q7A
ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.
19July2000
Q7
CurrentStep4version
Q7A
ApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.
10November2000
Q7
GOODMANUFACTURINGPRACTICEGUIDEFORACTIVEPHARMACEUTICALINGREDIENTS
ICHHarmonisedTripartiteGuideline
HavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon10November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH
TableofContents目录
1.INTRODUCTION1.前言
1.1Objective1.1目的
1.2RegulatoryApplicability1.2法规的适用性
1.3Scope1.3范围
2.QUALITYMANAGEMENT2.质量管理
2.1Principles2.1总则
2.2ResponsibilitiesoftheQualityUnit（s）2.2质量部门的责任
2.3ResponsibilityforProductionActivities2.3生产的职责
2.4InternalAudits（SelfInspection）2.4内部审计（自检）
2.5ProductQualityReview2.5产品质量回顾
3.PERSONNEL3.人员
3.1PersonnelQualifications3.1人员资格
3.2PersonnelHygiene3.2个人卫生
3.3Consultants3.3顾问
4.BUILDINGSANDFACILITIES4.建筑和设施
4.1DesignandConstruction4.1设计和建造
4.2Utilities4.2公用设施
4.3Water4.3水
4.4Containment4.4特殊限制
4.5Lighting4.5照明
4.6SewageandRefuse4.6污物和废弃物
4.7SanitationandMaintenance4.7卫生和维护
5.PROCESSEQUIPMENT5.工艺设备
5.1DesignandConstruction5.1设计和建造
5.2EquipmentMaintenanceandCleaning5.2设备维护和清洁
5.3Calibration5.3校验
5.4ComputerizedSystems5.4计算机控制系统
6.DOCUMENTATIONANDRECORDS6.文件和记录
6.1DocumentationSystemandSpecifications6.1文件系统和质量标准
6.2EquipmentcleaningandUseRecord6.2设备的清洁和使用记录
6.3RecordsofRawMaterials,Intermediates,6.3原料、中间体、原料药的标签和包装材料的记录
APILabelingandPackagingMaterials
6.4MasterProductionInstructions6.4主生产指令（主生产和控制记录）
（MasterProductionandControlRecords）
6.5BatchProductionRecords6.5批生产记录（批生产和控制记录）
（BatchProductionandControlRecords）
6.6LaboratoryControlRecords6.6实验室控制记录
6.7BatchProductionRecordReview6.7批生产记录审核
7.MATERIALSMANAGEMENT7.物料管理
7.1GeneralControls7.1一般要求
7.2ReceiptandQuarantine7.2接收和待验
7.3SamplingandTestingofIncomingProductionMaterials7.3来料的取样与检测
7.4Storage7.4储存
7.5Re-evaluation7.5再评价
8.PRODUCTIONANDIN-PROCESSCONTROLS8.生产管理和生产过程控制
8.1ProductionOperations8.1生产管理
8.2TimeLimits8.2时限
8.3In-processSamplingandControls8.3生产过程中的取样和控制
8.4BlendingBatchesofIntermediatesorAPIs8.4中间体或原料药的混批
8.5ContaminationControl8.5污染控制
9.PACKAGINGANDIDENTIFICATION9.原料药和中间体的包装和贴签
LABELINGOFAPIsANDINTERMEDIATES
9.1General9.1通则
9.2PackagingMaterials9.2包装材料
9.3LabelIssuanceandControl9.3标签发放与管理
9.4PackagingandLabelingOperations9.4包装和贴签管理
10.STORAGEANDDISTRIBUTION10.储存和分发
10.1WarehousingProcedures10.1入库程序
10.2DistributionProcedures10.2分发程序
11.LABORATORYCONTROLS11.实验室管理
11.1GeneralControls11.1通则
11.2TestingofIntermediatesandAPIs11.2中间体和原料药的检测
11.3ValidationofAnalyticalProcedures11.3分析方法的验证
11.4CertificatesofAnalysis11.4检验报告
11.5StabilityMonitoringofAPIs11.5原料药的稳定性考察
11.6ExpiryandRetestDating11.6有效期和复验期
11.7Reserve/RetentionSamples11.7留样
12.VALIDATION12.验证
12.1ValidationPolicy12.1验证方针
12.2ValidationDocumentation12.2验证文件
12.3Qualification12.3确认
12.4ApproachestoProcessValidation12.4工艺验证的方法
12.5ProcessValidationProgram12.5工艺验证的程序
12.6PeriodicReviewofValidatedSystems12.6对已验证的系统的定期回顾
12.7CleaningValidation12.7清洗验证
12.8ValidationofAnalyticalMethods12.8分析方法的验证
13.CHANGECONTROL13.变更控制
14.REJECTIONANDRE-USEOFMATERIALS14.物料的拒收和再利用
14.1Rejection14.1拒收
14.2Reprocessing14.2返工
14.3Reworking14.3重新加工
14.4RecoveryofMaterialsandSolvents14.4物料与溶剂的回收
14.5Returns14.5退货
15.COMPLAINTSANDRECALLS15.投诉与召回
16.CONTRACTMANUFACTURERS16.协议生产商（包括实验室）
（INCLUDINGLABORATORIES）
17.AGENTS,BROKERS,TRADERS,DISTRIBUTORS,17.代理商、经纪人、贸易商、经销商、重新包装者
REPACKERS,ANDRELABELLERS和重新贴签者
17.1Applicability17.1适用性
17.2TraceabilityofDistributedAPIsandIntermediates17.2已分发的原料药和中间体的可追溯性
17.3QualityManagement17.3质量管理
17.4Repackaging,Relabeling,andHoldingofAPIsandIntermediates17.4原料药和中间体的重新包装、重新贴签和待检
17.5Stability17.5稳定性
17.6TransferofInformation17.6信息的传达
17.7HandlingofComplaintsandRecalls17.7投诉和召回的处理
17.8HandlingofReturns17.8退货的处理
18.SpecificGuidanceforAPIsManufacturedbyCell18.用细胞繁殖/发酵生产的原料药的特殊指南
Culture/Fermentation
18.1General18.1总则
18.2CellBankMaintenanceandRecordKeeping18.2细胞库的维护和记录的保存
18.3CellCulture/Fermentation18.3细胞繁殖/发酵
18.4Harvesting,IsolationandPurification18.4收取、分离和精制
18.5ViralRemoval/Inactivationsteps18.5病毒的去除/灭活步骤
19.APIsforUseinClinicalTrials19.用于临床研究的原料药
19.1General19.1总则
19.2Quality19.2质量
19.3EquipmentandFacilities19.3设备和设施
19.4ControlofRawMaterials19.4原料的控制
19.5Production19.5生产
19.6Validation19.6验证
19.7Changes19.7变更
19.8LaboratoryControls19.8实验室控制
19.9Documentation19.9文件
20.Glossary20.术语
1.INTRODUCTION1.简介
1.1Objective1.1目的
Thisdocumentisintendedtoprovideguidanceregardinggoodmanufacturingpractice（GMP）forthemanufacturingofactivepharmaceuticalingredients（APIs）underanappropriatesystemformanagingquality.ItisalsointendedtohelpensurethatAPIsmeetthequalityandpuritycharacteristicsthattheypurport,orarerepresented,topossess.
本文件旨在提供在适当的体系下为了控制生产原料药的质量而实施的药品生产质量管理规范（GMP）的指南。
它也有助于帮助确保活性药物成分（APIs）符合其应有的质量和纯度要求。
Inthisguidance,thetermmanufacturingisdefinedtoincludealloperationsofreceiptofmaterials,production,packaging,repackaging,labeling,relabeling,qualitycontrol,release,storageanddistributionofAPIsandtherelatedcontrols.Inthisguidance,thetermshouldidentifiesrecommendationsthat,whenfollowed,willensurecompliancewithCGMPs.Analternativeapproachmaybeusedifsuchapproachsatisfiestherequirementsoftheapplicablestatues.Forthepurposesofthisguidance,thetermscurrentgoodmanufacturingpracticesandgoodmanufacturingpracticesareequivalent.
本指南中的“生产”定义为包括物料接收、生产、包装、重新包装、贴签、重新贴签、质量控制、放行、原料药的储存和分发及其相关控制的所有操作。
本指南中，“应当”一词表示希望采用的建议，除非证明其不适用或者可用一种已证明有同等或更高质量保证水平的供选物来替代。
本指南中的“现行优良生产管理规范（cGMP）”和“优良生产管理规范（GMP）”是等同的。
Theguidanceasawholedoesnotcoversafetyaspectsforthepersonnelengagedinmanufacturing,noraspectsrelatedtoprotecting
theenvironment.Thesecontrolsareinherentresponsibilitiesofthemanufacturerandaregovernedbynationallaws.
本指南在总体上未涉及生产人员的安全问题，亦不包括环保方面的内容。
这方面的管理是生产者固有的责任，也是国家法律规定的。
Thisguidanceisnotintendedtodefineregistrationand/orfilingrequirementsormodifypharmacopoeialrequirements.This
guidancedoesnotaffecttheabilityoftheresponsibleregulatoryagencytoestablishspecificregistration/filingrequirements
regardingAPIswithinthecontextofmarketing/manufacturingauthorizationsordrugapplications.Allcommitmentsinregistration/filingdocumentsshouldbemet.
本指南未规定注册/归档的要求、或修改药典的要求。
本指南不影响负责药政审理部门在原料药上市/制造授权或药品申请方面建立特定注册/归档要求的能力。
注册/归档的所有承诺必须做到。
1.2RegulatoryApplicability1.2法规的适用性
Withintheworldcommunity,materialsmayvaryastotheirlegalclassificationasanAPI.WhenamaterialisclassifiedasanAPIintheregionorcountryinwhichitismanufacturedorusedinadrugproduct,itshouldbemanufacturedaccordingtothisguidance.
在世界范围内对原料药的法定定义是各不相同的。
当某种物料在其制造或用于药品的地区或国家被称为原料药，就应该按照本指南进行生产。
1.3Scope1.3范围
ThisguidanceappliestothemanufactureofAPIsforuseinhumandrug（medicinal）products.ItappliestothemanufactureofsterileAPIsonlyuptothepointimmediatelypriortotheAPIsbeingrenderedsterile.ThesterilizationandasepticprocessingofsterileAPIsarenotcoveredbythisguidance,butshouldbeperformedinaccordancewithGMPguidancesfordrug（medicinal）productsasdefinedbylocalauthorities.
本文件适用于人用药品（医疗用品）所含原料药的生产。
它适用于无菌原料药在灭菌前的步骤。
本指南不包括无菌原料药的消毒和灭菌工艺，但是，应当符合地方当局所规定的药品（医疗用品）生产的GMP指南。
ThisguidancecoversAPIsthataremanufacturedbychemicalsynthesis,extraction,cellculture/fermentation,recoveryfromnaturalsources,oranycombinationoftheseprocesses.SpecificguidanceforAPIsmanufacturedbycellculture/fermentationisdescribedinSection18.
本文件适用于通过化学合成、提取、细胞培养/发酵，通过从自然资源回收，或通过这些工艺的结合而得到的原料药。
通过细胞培养/发酵生产的原料药的特殊指南则在第18章论述。
Thisguidanceexcludesallvaccines,wholecells,wholebloodandplasma,bloodandplasmaderivatives（plasmafractionation）,and
genetherapyAPIs.However,itdoesincludeAPIsthatareproducedusingbloodorplasmaasrawmaterials.Notethatcellsubstrates（mammalian,plant,insectormicrobialcells,tissueoranimalsourcesincludingtransgenicanimals）andearlyprocessstepsmaybesubjecttoGMPbutarenotcoveredbythisguidance.Inaddition,theguidancedoesnotapplytomedicalgases,bulk-packageddrug（medicinal）products（e.g.,tabletsorcapsul
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