ispe指南目錄

1、ISPE指南按系列分類的目錄清單：GAMP5?GAMP5:ARiskBasedApproachtoCompliantGxPComputerizedSystems?GAMP5:保證GXP計算機系統(tǒng)符合性的基于風險的方法GAMPGoodPracticeGuides?ARiskBasedApproachtoCalibrationManagement(SecondEdition)?基于風險的校正管理方法（第二版）?ARiskBasedAppro

2、achtoElectronicRecdsSignatures?基于風險的電子記錄和簽名方法?ARiskBasedApproachtoGxPCompliantLabatyComputerizedSystems(SecondEdition)?基于風險的GXP符合性實驗室計算機化系統(tǒng)方法（第二版）?ARiskBasedApproachtoGxPProcessControlSystems(SecondEdition)?基于風險的GXP工藝控制體

3、系方法（第二版）?ARiskBasedApproachtoOperationofGxPComputerizedSystemsACompanionVolumetoGAMP5?基于風險的GXP計算機系統(tǒng)操作方法GAMP5姊妹篇?ARiskBasedApproachtoRegulatedMobileApplications?基于風險的移動APP管理方法?ARiskBasedApproachtoTestingofGxPSystems(Secon

4、dEdition)?基于風險的GXP系統(tǒng)檢測方法（第二版）?ElectronicDataArchiving?電子數(shù)據(jù)歸檔?GlobalInfmationSystemsControlCompliance?全球信息系統(tǒng)控制和符合性?ITInfrastructureControlCompliance?IT基礎設施控制和符合性?LegacySystems?遺留系統(tǒng)?ManufacturingExecutionSystems–AStrategic

5、ProgramManagementApproach?生產(chǎn)執(zhí)行系統(tǒng)—策略和編程管理方法?GAMPGoodPracticeGuidesUnderDevelopment?制訂中的GAMPGPGISPEBaselinePharmaceuticalEngineeringGuidesfNewRenovatedFacilitiesISPE基準：新設施和創(chuàng)新型設施藥品工程指南?ISPEGoodPracticeGuide:ComparatManageme

6、nt?ISPEGPG：對照組管理?ISPEGoodPracticeGuide:DevelopmentofInvestigationalTherapeuticBiologicalProducts?ISPEGPG：臨床前治療用生物產(chǎn)品開發(fā)?ISPEGoodPracticeGuide:GoodEngineeringPractice?ISPEGPG：優(yōu)良工程規(guī)范?ISPEGoodPracticeGuide:HarmonizingtheDefin

7、itionUseofNonInvestigationalMedicinalProducts(NIMPs)?ISPEGPG：協(xié)調(diào)非臨床前藥品的定義和使用?ISPEGoodPracticeGuide:HeatingVentilationAirConditioning(HVAC)?ISPEGPG：HVAC?ISPEGoodPracticeGuide:InteractiveResponseTechnology?ISPEGPG：互動反饋技術?IS

8、PEGoodPracticeGuide:Maintenance?ISPEGPG：維護?ISPEGoodPracticeGuide:OzoneSanitizationofPharmaceuticalWaterSystem?ISPEGPG：制藥用水系統(tǒng)的臭氧消毒?ISPEGoodPracticeGuide:PackagingLabelingWarehousingFacilities?ISPEGPG：包裝、貼標和倉儲設計?ISPEGoodPr

9、acticeGuide:ProcessGases?ISPEGPG：工藝用氣?ISPEGoodPracticeGuide:ProjectManagementfthePharmaceuticalIndustry?ISPEGPG：制藥行業(yè)的項目管理?ISPEGoodPracticeGuide:QualityLabatyFacilities?ISPEGPG：質(zhì)量化驗室設施?ISPEGoodPracticeGuide:TechnologyTran

10、sfer(SecondEdition)?ISPEGPG：技術轉移（第二版）（新出）?ISPEGoodPracticeGuidesUnderDevelopment?制訂中的ISPEGPGPQLIGuides藥品質(zhì)量生命周期實施指南?PQLIOverviewGoodPracticeGuide?PQLI概覽GPG?ProductQualityLifecycleImplementation(PQLI)fromConcepttoContinual

11、ImprovementPart1:ProductRealizationusingQbDConceptsPrinciples?從概念到持續(xù)改進的藥品質(zhì)量生命周期實施（PQLI）第一部分：利用質(zhì)量源于設計（QbD）實現(xiàn)實現(xiàn)，概念和原則?ProductQualityLifecycleImplementation(PQLI)fromConcepttoContinualImprovementPart2:ProductRealizationusin