06 ICH Q7官方问答中英对照Word下载.docx

06 ICH Q7官方问答中英对照Word下载.docx

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DocumentHistory

ICHQ7指南：

原料药GMP指南

问答

2015-6-10

Code

History

Date

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 

#

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

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

Whatismeantby‘qu