PDA技術(shù)報告清單2023年

PDA〔2023〕1.ValidationofMoistHeatSterilizationProcesses:CycleDesign,Development,QualificationandOngoingControlRevised2023(Published1980)濕熱滅菌工藝驗(yàn)證：循環(huán)設(shè)計、研發(fā)、確認(rèn)和持續(xù)掌握，修訂2023ValidationofDryHeatProcessesUsedforDepyrogenationandSterilizationRevised2023(Published1981)0100343506用于除熱源和滅菌的干熱工藝驗(yàn)證，修訂2023DesignConceptsfortheValidationofWater-for-InjectionSystems1983注射用水系統(tǒng)驗(yàn)證的設(shè)計概念，1983SterilePharmaceuticalPackaging:CompatibilityandStability1984無菌制劑包裝：相容性和穩(wěn)定性，19847.Depyrogenation19851985ReviewofCommerciallyAvailableParticulateMeasurementSystems1988商業(yè)可選購的顆粒物檢測系統(tǒng)審核，1988ParenteralFormulationsofProteinsandPeptides:StabilityandStabilizers1988蛋白質(zhì)和多肽注射制劑：穩(wěn)定性和穩(wěn)定劑，198811.SterilizationofParenteralsbyGammaRadiation1988靜脈注射伽馬輻射滅菌，1988SiliconizationofParenteralDrugPackagingComponents1988靜脈注射劑藥品包裝組分硅化處理，1988FundamentalsofanEnvironmentalMonitoringProgramRevised2023(Published1990)環(huán)境監(jiān)測打算原則，修訂2023ValidationofColumn-BasedChromatographyProcessesforthePurificationofProteinsRevised2023(Published1992)蛋白純化用柱色譜工藝驗(yàn)證，修訂2023ValidationofTangentialFlowFiltrationinBiopharmaceuticalApplicationsRevised2023(Published1992)生物制藥用正切流過濾驗(yàn)證，修訂2023EffectofGammaIrradiationonElastomericClosures1992人造橡膠塞伽馬輻射效應(yīng)，1992CurrentPracticesintheValidationofAsepticProcessing--19921993無菌工藝驗(yàn)證現(xiàn)行標(biāo)準(zhǔn)，1992，1993ReportontheValidationofComputer-RelatedSystems1995計算機(jī)相關(guān)系統(tǒng)驗(yàn)證報告，199519.Rapid/AutomatedIDMethodsSurvey1990快速/自動ID方法調(diào)查，1990ReportonSurveyofCurrentIndustryGowningPractices1990行業(yè)現(xiàn)行更衣標(biāo)準(zhǔn)調(diào)查報告，1990BioburdenRecoveryValidation1990生物負(fù)載回收率驗(yàn)證，1990ProcessSimulationforAsepticallyFilledProductsRevised2023(Published1996)無菌灌裝藥品工藝模擬，修訂2023IndustrySurveyonCurrentSterileFiltrationPractices1996現(xiàn)行無菌過濾實(shí)踐行業(yè)調(diào)查，1996CurrentPracticesintheValidationofAsepticProcessing–19961996無菌工藝驗(yàn)證現(xiàn)行標(biāo)準(zhǔn)，1996BlendUniformityAnalysis:ValidationandIn-ProcessTesting1997混合均一性分析：驗(yàn)證和中控測試，1997SterilizingFiltrationofLiquidsRevised2023(Published1998)液體無菌過濾，修訂2023PharmaceuticalPackageIntegrity19981998ProcessSimulationTestingforSterileBulkPharmaceuticalChemicalsRevised2023(Published1998)無菌散裝藥用化學(xué)物工藝模擬測試，修訂2023PointstoConsiderforCleaningValidationRevised2023(Published1998)清潔驗(yàn)證的考慮要點(diǎn)，修訂2023ParametricReleaseofPharmaceuticalsandMedicalDeviceProductsTerminallySterilizedbyMoistHeatRevised2023(Published1999)最終濕熱滅菌的藥物和醫(yī)療器械參數(shù)放行，修訂2023ValidationandQualificationofComputerizedLaboratoryDataAcquisitionSystems1999計算機(jī)化試驗(yàn)室數(shù)據(jù)獵取系統(tǒng)驗(yàn)證和確認(rèn)，1999AuditingofSuppliersProvidingComputerProductsandServicesforRegulatedPharmaceuticalOperationsRevised2023(Published1999)供給受法規(guī)治理的藥物操作用計算機(jī)產(chǎn)品和效勞的供給商審計，修訂2023Evaluation,ValidationandImplementationofAlternativeandRapidMicrobiologicalMethodsRevised2023(Published2023)替代性和快速微生物方法的評估、驗(yàn)證和實(shí)施，修訂2023DesignandValidationofIsolateSystemsfortheManufacturingandTestingofHealthCareProducts2023保健藥品的生產(chǎn)和檢測分別系統(tǒng)的設(shè)計和驗(yàn)證，2023AProposedTrainingModelfortheMicrobiologicalFunctioninthePharmaceuticalIndustry2023制藥行業(yè)微生物功能培訓(xùn)模式建議，2023CurrentPracticesintheValidationofAsepticProcessing–20232023--2023，2023ManufacturingChromatographySystemsPost-ApprovalChanges:(ChromPAC):Chemistry,ManufacturingandControlsDocumentation2023批準(zhǔn)后生產(chǎn)用色譜系統(tǒng)：研發(fā)、生產(chǎn)和掌握文件，2023GuidanceforTemperature-ControlledMedicinalProducts:MaintainingtheQualityofTemperature-SensitiveMedicinalProductsthroughtheTransportationEnvironment2023溫度受控藥物指南：通過運(yùn)輸環(huán)境來維護(hù)對溫度敏感的藥物的質(zhì)量，2023SterilizationFiltrationofGases20232023VirusFiltration20232023ProcessValidationofProteinManufacturing2023蛋白質(zhì)生產(chǎn)的工藝驗(yàn)證，2023IdentificationandClassificationofNonconformitiesinMoldedandTubularGlassContainersforPharmaceuticalManufacturingRevised2023(Published2023)藥物生產(chǎn)用模型制備和管式玻璃容器的識別和分類，修訂2023QualityRiskManagementforAsepticProcesses2023無菌工藝的質(zhì)量風(fēng)險治理，2023FiltrationofLiquidsUsingCellulose-BasedDepthFilters2023使用纖維素根底深層過濾器的液體過濾，2023LastMile:GuidanceforGoodDistributionPracticesforPharmaceuticalProductstotheEndUser2023最終里程：給最終用戶的藥物優(yōu)良銷售標(biāo)準(zhǔn)指南，2023PreparationofVirusSpikesUsedforVirusClearanceStudies2023用于病毒去除爭論的病毒加標(biāo)樣制備，2023MoistHeatSterilizerSystems:Design,Commissioning,Operation,QualificationandMaintenance2023濕熱滅菌系統(tǒng)：設(shè)計、調(diào)試、運(yùn)行、確認(rèn)和維護(hù)，2023PointstoConsiderforBiotechnologyCleaningValidation2023生物制品清潔驗(yàn)證考慮要點(diǎn)，2023AlternativeMethodsforMycoplasmaTesting2023支原體測試替代性方法，2023BiologicalIndicatorsforGasandVapor-PhaseDecontaminationProcesses:Specification,Manufacture,ControlandUse2023氣體和蒸汽相除污染工藝生物指示劑：質(zhì)量標(biāo)準(zhǔn)、生產(chǎn)、掌握和使用，2023GuidanceGoodDistributionPracticesforthePharmaceuticalSupplyChain2023藥品供給鏈優(yōu)良銷售標(biāo)準(zhǔn)指南，2023GuidanceforIndustry:StabilityTestingtoSupportDistributionofNewDrugProducts2023行業(yè)指南：支持藥銷售的穩(wěn)定性測試，2023ImplementationofQualityRiskManagementforPharmaceuticalandBiotechnologyManufacturingOperations2023藥品和生物制品生產(chǎn)操作的質(zhì)量風(fēng)險治理實(shí)施，202354-2.ImplementationofQualityRiskManagementforPharmaceuticalandBiotechnologyManufacturingOperation:Annex1:CaseStudyExamplesforQualityRiskManagementinPackagingandLabeling20231：包裝和標(biāo)識中的質(zhì)量風(fēng)險治理案例爭論，202354-3.ImplementationofQualityRiskManagementforPharmaceuticalandBiotechnologyManufacturingOperationsAnnex2:CaseStudiesintheManufacturingofPharmaceuticalDrugProducts20232：藥品生產(chǎn)中的質(zhì)量風(fēng)險治理案例爭論，202354-4.ImplementationofQualityRiskManagementforPharmaceuticalandBiotechnologyManufacturingOperationsAnnex3:CaseStudiesintheManufacturingofBiotechnologicalBulkDrugSubstances20233：生物散裝藥用物質(zhì)生產(chǎn)中的質(zhì)量風(fēng)險治理案例爭論，2023DetectionandMitigationof2,4,6-Tribromoanisoleand2,4,6-TrichloroanisoleTaintsandOdorsinthePharmaceuticalandConsumerHealthcareIndustries20232，4，6-2，4，6-三氯苯甲醚污染和氣味的檢測和移除，2023ApplicationofPhase-AppropriateQualitySystemsandCGMPtotheDevelopmentofTherapeuticProteinDrugSubstance2023治療用蛋白質(zhì)藥用物質(zhì)研發(fā)中與階段相適當(dāng)?shù)馁|(zhì)量體系和CGMP應(yīng)用，2023AnalyticalMethodValidationandTransferforBiotechnologyProducts2023生物制品的分析方法驗(yàn)證和轉(zhuǎn)移，2023RiskManagementforTemperature-ControlledDistribution2023溫度受控銷售風(fēng)險治理，2023UtilizationofStatisticalMethodsforProductionMonitoring2023生產(chǎn)監(jiān)測用統(tǒng)計學(xué)方