已上化学仿制药注射剂一致性评价技术要求

已上化学仿制药注射剂一致性评价技术要求已上化学仿制药注射剂一致性评价技术要求/21参考文献：、 ICH Steering Committee, Harmonised TripartiteGuidelineQ8:PharmaceuticalDevelopment.August,2009、 ICH Steering Committee. Harmonised TripartiteGuidelineQ1A:StabilityTestingofNewDrugSubstancesandProducts.2003、 ICH Steering Committee. Harmonised TripartiteGuidelineQ3D:GuidelineforElementalImpurities.2014、 ICH Steering Committee. Harmonised TripartiteGuidelineM7:AssessmentandControlofDNAReactive（Mutagenic）ImpuritiesinPharmaceuticalstoLimitPotentialCarcinogenicRisk.2017、国家食品药品监督管理总局 .《化学药品新注册分类申报资料要求（试行）》（2016年第80号）、化学药品注射剂基本技术要求（试行）（国食药监注[2008]7号）、国家食品药品监督管理总局药品审评中心 .《灭菌 /无菌工艺验证指导原则》（征求意见稿）、国家食品药品监督管理总局食品药品审核查验中心《除菌过滤技术及应用指南》（征求意见稿）、国家食品药品监督管理总局 .《化学药物（原料药和制剂）稳定性研究技术指导原则（修订）》、国家食品药品监督管理总局 .《化学药品注射剂与塑料包装材料相容性研究技术指导原则（试行） 》（国食药监注[2012]267号）、国家食品药品监督管理总局 .《化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则（试行）》（2015年第40号）、国家食品药品监督管理总局药品审评中心 .《化学药品与弹性体密封件相容性研究技术指导原则》（征求意见稿）、FoodandDrugAdministration,CenterforDrugEvaluationandResearch（CDER）,OfficeofPharmaceuticalQuality.ManualofPoliciesandProcedures（MAPP）,PolicyandProcedures,5040.1,ProductQualityMicrobiologyInformationintheCommonTechnicalDocument-Quality（CTD-Q）.January2017、FoodandDrugAdministration,CenterforDrugEvaluationandResearch（CDER）.GuidanceforIndustry:ANDASubmissions-Refuse-to-ReceiveStandards.December,2016、FoodandDrugAdministration,CenterforDrugEvaluationandResearch(CDER).GuidanceforIndustry:ANDASubmissions-RefusetoReceiveforLackofJustificationofImpurityLimits.August2016、FoodandDrugAdministration,CenterforDrugEvaluationandResearch(CDER),andCenterforVeterinaryMedicine(CVM).GuidanceforIndustryfortheSubmissionDocumentationforSterilizationProcessValidationinApplicationsforHumanandVeterinaryDrugProducts.November1994、FoodandDrugAdministration,CenterforDrugEvaluationandResearch(CDER)andCenterforBiologicsEvaluationandResearch(CBER).GuidanceforIndustry:AllowableExcessVolumeandLabeledVialFillSizeinInjectableDrugandBiologicalProducts.June2015、FoodandDrugAdministration,CenterforBiologicsEvaluationandResearch,CenterforDrugEvaluationandResearch,CenterforDevicesandRadiologicalHealth,andCenterforVeterinaryMedicine.GuidanceforIndustry:ContainerandClosureSystemIntegrityTestinginLieuofSterilityTestingasaComponentoftheStabilityProtocolforSterileProducts.February2008、FoodandDrugAdministration,CenterforDrugEvaluationandResearch(CDER).GuidanceforIndustry:ChangestoanApprovedNDAorANDA.April2004、FoodandDrugAdministration,CenterforDrugEvaluationandResearch(CDER).GuidanceforIndustry:ANDAs:StabilityTestingofDrugSubstancesandProducts,QuestionsandAnswers.May2014、USP<1207>、<1207.1>、<1207.2>、<1207.3>、EuropeanMedicinesAgency,CommitteeforMedicinalProductsforHumanUse(CHMP).EMA/CHMP/QWP/799402/2011: ReflectionPaperonthePharmaceuticalDevelopmentofIntravenousMedicinalProductsContainingActiveSubstancesSolubilisedinMicellarSystems.、EuropeanMedicinesAgency,CommitteeforMedicinalProductsforHumanUse(CHMP).GuidelineontheInvestigationofBioequivalence.January2010、HealthCanada,HealthProductsandFoodBranch.GUIDANCEFORINDUSTRY:PharmaceuticalQualityofAqueousSolutions.Febraury2008、FoodandDrugAdministration,CenterforDrugEvaluationandResearch(CDER).Guidances(Drugs)：Generics:/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064995.htm、FoodandDrugAdministration,CenterforDrugEvaluationandResearch(CDER).GenericDrugDevelopment:/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm、FoodandDrugAdministration,CenterforDrugEvaluationandResearch(CDER),OfficeofGenericDrugs.FilingReviewofAbbreviatedNewDrugApplications,MAPP5200.14.September2017.、EuropeanMedicinesAgency,CommitteeforProprietaryMedicineProducts.NoteforGuidanceonIn-useStabilityTestingofHumanMedicineProducts.September2001.、EuropeanMedicinesAgenc