PDA技术报告清单2023年

PDA〔2023〕1.ValidationofMoistHeatSterilizationProcesses:CycleDesign,Development,QualificationandOngoingControlRevised2023(Published1980)湿热灭菌工艺验证：循环设计、研发、确认和持续掌握，修订2023ValidationofDryHeatProcessesUsedforDepyrogenationandSterilizationRevised2023(Published1981)0100343506用于除热源和灭菌的干热工艺验证，修订2023DesignConceptsfortheValidationofWater-for-InjectionSystems1983注射用水系统验证的设计概念，1983SterilePharmaceuticalPackaging:CompatibilityandStability1984无菌制剂包装：相容性和稳定性，19847.Depyrogenation19851985ReviewofCommerciallyAvailableParticulateMeasurementSystems1988商业可选购的颗粒物检测系统审核，1988ParenteralFormulationsofProteinsandPeptides:StabilityandStabilizers1988蛋白质和多肽注射制剂：稳定性和稳定剂，198811.SterilizationofParenteralsbyGammaRadiation1988静脉注射伽马辐射灭菌，1988SiliconizationofParenteralDrugPackagingComponents1988静脉注射剂药品包装组分硅化处理，1988FundamentalsofanEnvironmentalMonitoringProgramRevised2023(Published1990)环境监测打算原则，修订2023ValidationofColumn-BasedChromatographyProcessesforthePurificationofProteinsRevised2023(Published1992)蛋白纯化用柱色谱工艺验证，修订2023ValidationofTangentialFlowFiltrationinBiopharmaceuticalApplicationsRevised2023(Published1992)生物制药用正切流过滤验证，修订2023EffectofGammaIrradiationonElastomericClosures1992人造橡胶塞伽马辐射效应，1992CurrentPracticesintheValidationofAsepticProcessing--19921993无菌工艺验证现行标准，1992，1993ReportontheValidationofComputer-RelatedSystems1995计算机相关系统验证报告，199519.Rapid/AutomatedIDMethodsSurvey1990快速/自动ID方法调查，1990ReportonSurveyofCurrentIndustryGowningPractices1990行业现行更衣标准调查报告，1990BioburdenRecoveryValidation1990生物负载回收率验证，1990ProcessSimulationforAsepticallyFilledProductsRevised2023(Published1996)无菌灌装药品工艺模拟，修订2023IndustrySurveyonCurrentSterileFiltrationPractices1996现行无菌过滤实践行业调查，1996CurrentPracticesintheValidationofAsepticProcessing–19961996无菌工艺验证现行标准，1996BlendUniformityAnalysis:ValidationandIn-ProcessTesting1997混合均一性分析：验证和中控测试，1997SterilizingFiltrationofLiquidsRevised2023(Published1998)液体无菌过滤，修订2023PharmaceuticalPackageIntegrity19981998ProcessSimulationTestingforSterileBulkPharmaceuticalChemicalsRevised2023(Published1998)无菌散装药用化学物工艺模拟测试，修订2023PointstoConsiderforCleaningValidationRevised2023(Published1998)清洁验证的考虑要点，修订2023ParametricReleaseofPharmaceuticalsandMedicalDeviceProductsTerminallySterilizedbyMoistHeatRevised2023(Published1999)最终湿热灭菌的药物和医疗器械参数放行，修订2023ValidationandQualificationofComputerizedLaboratoryDataAcquisitionSystems1999计算机化试验室数据猎取系统验证和确认，1999AuditingofSuppliersProvidingComputerProductsandServicesforRegulatedPharmaceuticalOperationsRevised2023(Published1999)供给受法规治理的药物操作用计算机产品和效劳的供给商审计，修订2023Evaluation,ValidationandImplementationofAlternativeandRapidMicrobiologicalMethodsRevised2023(Published2023)替代性和快速微生物方法的评估、验证和实施，修订2023DesignandValidationofIsolateSystemsfortheManufacturingandTestingofHealthCareProducts2023保健药品的生产和检测分别系统的设计和验证，2023AProposedTrainingModelfortheMicrobiologicalFunctioninthePharmaceuticalIndustry2023制药行业微生物功能培训模式建议，2023CurrentPracticesintheValidationofAsepticProcessing–20232023--2023，2023ManufacturingChromatographySystemsPost-ApprovalChanges:(ChromPAC):Chemistry,ManufacturingandControlsDocumentation2023批准后生产用色谱系统：研发、生产和掌握文件，2023GuidanceforTemperature-ControlledMedicinalProducts:MaintainingtheQualityofTemperature-SensitiveMedicinalProductsthroughtheTransportationEnvironment2023温度受控药物指南：通过运输环境来维护对温度敏感的药物的质量，2023SterilizationFiltrationofGases20232023VirusFiltration20232023ProcessValidationofProteinManufacturing2023蛋白质生产的工艺验证，2023IdentificationandClassificationofNonconformitiesinMoldedandTubularGlassContainersforPharmaceuticalManufacturingRevised2023(Published2023)药物生产用模型制备和管式玻璃容器的识别和分类，修订2023QualityRiskManagementforAsepticProcesses2023无菌工艺的质量风险治理，2023FiltrationofLiquidsUsingCellulose-BasedDepthFilters2023使用纤维素根底深层过滤器的液体过滤，2023LastMile:GuidanceforGoodDistributionPracticesforPharmaceuticalProductstotheEndUser2023最终里程：给最终用户的药物优良销售标准指南，2023PreparationofVirusSpikesUsedforVirusClearanceStudies2023用于病毒去除争论的病毒加标样制备，2023MoistHeatSterilizerSystems:Design,Commissioning,Operation,QualificationandMaintenance2023湿热灭菌系统：设计、调试、运行、确认和维护，2023PointstoConsiderforBiotechnologyCleaningValidation2023生物制品清洁验证考虑要点，2023AlternativeMethodsforMycoplasmaTesting2023支原体测试替代性方法，2023BiologicalIndicatorsforGasandVapor-PhaseDecontaminationProcesses:Specification,Manufacture,ControlandUse2023气体和蒸汽相除污染工艺生物指示剂：质量标准、生产、掌握和使用，2023GuidanceGoodDistributionPracticesforthePharmaceuticalSupplyChain2023药品供给链优良销售标准指南，2023GuidanceforIndustry:StabilityTestingtoSupportDistributionofNewDrugProducts2023行业指南：支持药销售的稳定性测试，2023ImplementationofQualityRiskManagementforPharmaceuticalandBiotechnologyManufacturingOperations2023药品和生物制品生产操作的质量风险治理实施，202354-2.ImplementationofQualityRiskManagementforPharmaceuticalandBiotechnologyManufacturingOperation:Annex1:CaseStudyExamplesforQualityRiskManagementinPackagingandLabeling20231：包装和标识中的质量风险治理案例争论，202354-3.ImplementationofQualityRiskManagementforPharmaceuticalandBiotechnologyManufacturingOperationsAnnex2:CaseStudiesintheManufacturingofPharmaceuticalDrugProducts20232：药品生产中的质量风险治理案例争论，202354-4.ImplementationofQualityRiskManagementforPharmaceuticalandBiotechnologyManufacturingOperationsAnnex3:CaseStudiesintheManufacturingofBiotechnologicalBulkDrugSubstances20233：生物散装药用物质生产中的质量风险治理案例争论，2023DetectionandMitigationof2,4,6-Tribromoanisoleand2,4,6-TrichloroanisoleTaintsandOdorsinthePharmaceuticalandConsumerHealthcareIndustries20232，4，6-2，4，6-三氯苯甲醚污染和气味的检测和移除，2023ApplicationofPhase-AppropriateQualitySystemsandCGMPtotheDevelopmentofTherapeuticProteinDrugSubstance2023治疗用蛋白质药用物质研发中与阶段相适当的质量体系和CGMP应用，2023AnalyticalMethodValidationandTransferforBiotechnologyProducts2023生物制品的分析方法验证和转移，2023RiskManagementforTemperature-ControlledDistribution2023温度受控销售风险治理，2023UtilizationofStatisticalMethodsforProductionMonitoring2023生产监测用统计学方