ICH Q7官方问答中英0617.docx
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ICH Q7官方问答中英0617.docx
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ICHQ7官方问答中英0617
Q7ImplementationWorkingGroup
ICHQ7Guideline:
GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients
QuestionsandAnswers
Currentversion
dated10June2015
InordertofacilitatetheimplementationoftheQ7Guidelines,
theICHExpertshavedevelopedaseriesofQ&As:
Q7Q&As
DocumentHistory
ICHQ7指南:
原料药GMP指南
问答
2015-6-10
Code
History
Date
Q7Q&As
ApprovalbytheICHSteeringCommitteeunder Step4
10June2015
References
Thesedocumentsarepublishedat www.ich.org.
ICHE2EPharmacovigilancePlanningNovember2004
ICHQ1A(R2)StabilitytestingofnewdrugsubstanceandproductsFebruary2003
ICHQ5AQualityofBiotechnologicalProducts:
ViralSafetyEvaluationofBiotechnologyProductsDerived
fromCellLinesofHumanorAnimalOriginSeptember1999
ICHQ5BQualityofbiotechnologicalproducts:
Analysisoftheconstructincellsusedfortheproductionofr-DNAderivedproteinproductsNovember2005
ICHQ5DQualityofBiotechnologicalProducts:
DerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological/BiologicalProductsJuly1997
ICHQ6BSpecifications:
TestProceduresandAcceptanceCriteriaforBiotechnological/BiologicalProductsMarch1999
ICHQ7GoodManufacturingPracticeofAPIsNovember2000
ICHQ8(R2)PharmaceuticalDevelopmentAugust2009
PartI:
‘PharmaceuticalDevelopment’November2006
PartII:
‘AnnextoPharmaceuticalDevelopment’,November2008
ICHQ9QualityRiskManagementandtheICHQ9BriefingpackNovember2005
ICHQ10PharmaceuticalQualitySystemsJune2008
ICHQ-IWGTrainingProgrammeforICHQ8/Q9/Q10November2010
ICHQ11DevelopmentandManufacturingofActivePharmaceuticalIngredientsMay2012
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TableofContents
PREFACE.............................................................................................1
1.INTRODUCTION-SCOPE..........................................................................................2
2.QUALITYMANAGEMENT..........................................................................................2
3.PERSONNEL................................................................................................................................3
4.BUILDINGSANDFACILITIES–CONTAINMENT.....................................................................4
5.PROCESSEQUIPMENT–CLEANING...........................................................................................................5
6.DOCUMENTATIONANDRECORDS.....................................................................................6
7.MATERIALSMANAGEMENT......................................................................................7
8.PRODUCTIONANDIN-PROCESSCONTROLS............................................................................8
9.PACKAGINGANDIDENTIFICATIONLABELLINGOFAPISANDINTERMEDIATES....................................8
10.STORAGEANDDISTRIBUTION.............................................................................................8
11.LABORATORYCONTROLS.......................................................................................9
12.VALIDATION........................................................................................................11
13.CHANGECONTROL....................................................................................11
14.REJECTIONANDREUSEOFMATERIALS.....................................................12
15.COMPLAINTSANDRECALLS.............................................................................12
16.CONTRACTMANUFACTURERS(INCLUDINGLABORATORIES).................................................13
17.AGENTS,BROKERS,TRADERS,DISTRIBUTORS,REPACKERS,ANDRELABELLERS.......................14
18.SPECIFICGUIDANCEFORAPISMANUFACTUREDBYCELLCULTURE/FERMENTATION...........................................................15
19.APISFORUSEINCLINICALTRIALS................................15
20.GLOSSARY................................................................................16
21.ANNEX:
Q&ASLINKEDTOTHERESPECTIVESECTIONSOFICHQ7.............................17
PREFACE 前言
SincetheICHQ7Guidancewasfinalised,experiencewithimplementingtheguidanceworldwidehasgivenrisetorequestsforclarificationofuncertaintiesduetotheinterpretationofcertainsections.ThisQuestionandAnswer(Q&A)documentisintendedtorespondtothoserequests.
自从ICHQ7指南定稿,在全球实施中,有不少要求期望对一些内容的不确定性进行澄清。
本问答文件就是为了对这些咨询做出回应。
TheICHQ7documentshouldbereadinitsentiretyregardlessofthenatureofthemanufacturingactivitiesbeingconductedtofullyunderstandthelinkagesbetweencertainsectionsandsuccessfullyimplementappropriateGoodManufacturingpractices(GMPs)atallstagesoftheActivePharmaceuticalIngredients(API)supplychain,includingdistribution.AtableisprovidedasanAnnexofthisdocumentshowingthelinkbetweeneachQ&AandtherelevantSectionsofICHQ7andotherICHQualityguidance.
ICHQ7文件应作为整体阅读,而不管所实施的生产活动的特性如何,以便全面理解各部之间的联系,成功地在所有API供应链所有环节,包括销售中实施适当的GMP。
在本文的附录提供了一份表格,显示出各问答与章节之间的关联,以及ICHQ7与其它ICH质量指南之间的关联。
ICHwouldliketoacknowledgetheworkundertakenbythePharmaceuticalInspectionCo-operationScheme(PIC/S).PIC/ScontributedtothisdocumentbyselectingandreviewingrelevantQ&AsthathadbeencollectedfromtrainingsessionssincetheimplementationofQ7andtransferredtheoutputofthesereviewstotheICHQ7IWGforconsiderationandconsolidation,asappropriate.AdditionalquestionsweredevelopedbasedonresponsesfromanICHsurvey.PIC/SfurthercontributedtothedevelopmentofthedocumentasanICHInterestedParty.
IICH希望向PIC/S所做的工作致谢。
PIC/S选择和审核了自Q7实施以来在培训课程中收集的相关问答,并将其审核的结果转交给ICHQ7专家工作组供其讨论和成文。
还有一些问题是在ICH调查中收到的回复。
作为ICH利益相关方,PIC/S对本文的制订做出了贡献。
PleasenotethatICHQ7shouldbeappliedincombinationwiththeprincipleslaiddownfordevelopmentandmanufacturinginICHQ11(seedefinitionofAPIstartingmaterial;seealsoICHQ8(R2)PartII),QualityRiskManagement(ICHQ9),andPharmaceuticalQualitySystems(ICHQ10).GMPprinciplesasdescribedinICHQ7shouldbeappliedregardlesswhichapproachistakeninpharmaceuticaldevelopmentandmanufacturing.
请注意ICHQ7应与在ICHQ11(参见API起始物料定义,参见ICHQ8(R2)第II部分)、质量风险管理(ICHQ9)和药物质量体系(ICHQ10)中对药物研发和生产所给定的原则结合使用。
不管在药物研发和生产中使用的是何种方法,都应该应用在ICHQ7里所述的GMP原则。
ICHQ7alsodescribesprinciplesofGMPstobeappliedinthemanufactureofAPIsforuseinclinicaltrials(Section19)andforAPIsmanufacturedbycellculture/fermentation(Section18).
ICHQ7还描述以适用于临床试验用API(第19部分),以及细胞培养/发酵(第18部分)生产的GMP原则。
Q7QuestionsandAnswers 问答
#
DateofApproval
批准日期
Questions
问
Answers
答
1.INTRODUCTION–SCOPE概述---范围
1.1
June2015
ShouldGMPaccordingtoICHQ7beappliedformanufacturingStepsbeforethedefined‘APIstartingmaterial'i.e.,StepsnotidentifiedingreyinTable1?
ICHQ7doesnotapplytoStepspriortotheintroductionoftheAPIstartingmaterial.However,thereisanexpectationthatanappropriatelevelofcontrolssuitablefortheproductionoftheAPIstartingmaterialshouldbeapplied[ICHQ7,Section1.3].
Normally,the‘API-startingmaterial’isdefinedintheregulatoryfilingbytheapplicantandapprovedintheregulatoryreviewingprocess.Additionalguidanceisprovidedtodefineandjustify‘APIstartingmaterial’derivedfromvarioussources[ICHQ11,Section5];formastercellbanks,see[ICHQ5B;ICHQ5D].
ICHQ7的GMP内容是否适用于界定的原料药起始物料生产步骤,即表1中不是灰色的部分?
ICHQ7不适用于原料药起始物料之前的步骤。
但是,期望原料药起始物料的生产有适当的控制水平【ICHQ7,第1.3部分】。
一般来说,“原料药起始物料”是由申请人在法规申报时定义的,并由法规当局在审核过程中进行批准。
关于不同来源的“原料药起始物料”的定义和论证有另外的指南【ICHQ11第5部分】,母细胞库参见【ICHQ5B和ICHQ5D】。
1.2
June2015
DoesICHQ7applytomanufacturingStepsfortheadditionofsubstance(s)toanAPI(e.g.,tostabilisetheAPI)?
WhenamixtureisclassifiedintheregulatoryfilingasanAPIinaregionorcountryinwhichitisusedinadrugproduct,ICHQ7shouldbeappliedtothemanufacturingofthesemixtures[ICHQ7,Section1.2,20–seeGlossaryfordefinitionof‘API’].
ICHQ7适用于将其它物质加入原料的生产步骤吗(例如,加入使原料药稳定)?
如果一个混合物在法规注册时是作为一种原料药,在注册区域作为药品使用,则ICHQ7适用于这些混合生产步骤【ICHQ7第1.2,20部分---参见原料药定义】。
2.QUALITYMANAGEMENT质量管理
2.1
June2015
Whatismeantby‘qualityunit(s)independentfromproduction’?
Theintentoftheterm‘independent’istopreventanyconflictofinterestandensureunbiaseddecisionmakingregardingquality-relateddecisionsintheorganisationstructure.Thepersoninthequalityunitwhoisresponsibleforfinaldecision-making(e.g.,batchreleasedecision)shouldnothaveresponsibilitiesforproductionactivities[ICHQ7,Section2.13].
“质量部门独立于生产”是什么意思?
“独立”一词意在防止利益冲突,保证对与质量相关的决定能
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