201506-ICH-Q7官方问答(中英对照)

201506ICHQ7官方问答Q7ImplementationWorkingGroupICHQ7Guideline:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredientsQuestionsandAnswersCurrentversiondated10June2015InordertofacilitatetheimplementationoftheQ7Guidelines,theICHExpertshavedevelopedaseriesofQ&As:Q7Q&AsDocumentHistoryICHQ7指南：原料药GMP指南问答2015-6-10CodeHistoryDateQ7Q&AsApprovalbytheICHSteeringCommitteeunderStep410June2015ReferencesThesedocumentsarepublishedat(R2)StabilitytestingofnewdrugsubstanceandproductsFebruary2003ICHQ5AQualityofBiotechnologicalProducts:ViralSafetyEvaluationofBiotechnologyProductsDerivedfromCellLinesofHumanorAnimalOriginSeptember1999ICHQ5BQualityofbiotechnologicalproducts:Analysisoftheconstructincellsusedfortheproductionofr-DNAderivedproteinproductsNovember2005ICHQ5DQualityofBiotechnologicalProducts:DerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological/BiologicalProductsJuly1997ICHQ6BSpecifications:TestProceduresandAcceptanceCriteriaforBiotechnological/BiologicalProductsMarch1999ICHQ7GoodManufacturingPracticeofAPIsNovember2000ICHQ8(R2)PharmaceuticalDevelopmentAugust2009PartI:‘PharmaceuticalDevelopment’November2006PartII:‘AnnextoPharmaceuticalDevelopment’,November2008ICHQ9QualityRiskManagementandtheICHQ9BriefingpackNovember2005ICHQ10PharmaceuticalQualitySystemsJune2008ICHQ-IWGTrainingProgrammeforICHQ8/Q9/Q10November2010ICHQ11DevelopmentandManufacturingofActivePharmaceuticalIngredientsMay2012LegalNotice:Thisdocumentisprotectedbycopyrightandmaybeused,reproduced,incorporatedintootherworks,adapted,modified,translatedordistributedunderapubliclicenseprovidedthatICH'scopyrightinthedocumentisacknowledgedatalltimes.Incaseofanyadaption,modificationortranslationofthedocument,reasonablestepsmustbetakentoclearlylabel,demarcateorotherwiseidentifythatchangesweremadetoorbasedontheoriginaldocument.Anyimpressionthattheadaption,modificationortranslationoftheoriginaldocumentisendorsedorsponsoredbytheICHmustbeavoided.Thedocumentisprovidedasiswithoutwarrantyofanykind.InnoeventshalltheICHortheauthorsoftheoriginaldocumentbeliableforanyclaim,damagesorotherliabilityarisingfromtheuseofthedocument.Theabove-mentionedpermissionsdonotapplytocontentsuppliedbythirdparties.Therefore,fordocumentswherethecopyrightvestsinathirdparty,permissionforreproductionmustbeobtainedfromthiscopyrightholder.TableofContentsPREFACE.........................................................................................................................................11.INTRODUCTION-SCOPE.....................................................................................................22.QUALITYMANAGEMENT.....................................................................................................23.PERSONNEL................................................................................................................................34.BUILDINGSANDFACILITIES–CONTAINMENT............................................................45.PROCESSEQUIPMENT–CLEANING...............................................................................56.DOCUMENTATIONANDRECORDS.....................................................................................67.MATERIALSMANAGEMENT.................................................................................................78.PRODUCTIONANDIN-PROCESSCONTROLS................................................................89.PACKAGINGANDIDENTIFICATIONLABELLINGOFAPISANDINTERMEDIATES.......................................................................................................................810.STORAGEANDDISTRIBUTION.......................................................................................811.LABORATORYCONTROLS...............................................................................................912.VALIDATION.......................................................................................................................1113.CHANGECONTROL..........................................................................................................1114.REJECTIONANDREUSEOFMATERIALS................................................................1215.COMPLAINTSANDRECALLS........................................................................................1216.CONTRACTMANUFACTURERS(INCLUDINGLABORATORIES)......................................................................................................................1317.AGENTS,BROKERS,TRADERS,DISTRIBUTORS,REPACKERS,ANDRELABELLERS..........................................................................................................................1418.SPECIFICGUIDANCEFORAPISMANUFACTUREDBYCELLCULTURE/FERMENTATION...................................................................................................1519.APISFORUSEINCLINICALTRIALS............................................................................1520.GLOSSARY...........................................