蒸汽灭菌和冻干工艺的验证及风险分析 翻译版-CTP Giuseppe Ruggirell

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1、VALIDATION&RISKANALYSISSteamSterilizationandLyophilizzation蒸汽灭菌和冻干的验证及风险管理Aroutefromprocessprinciplestoasafeandcompliantproduct.Theawarenessofadocumentedevidence.药品安全、达标工艺原理的途径对文件和记录证据的理解PresentedbyMr.Villani2012-09JNCONTENT内容GMPandValidationGMP和验证Qualification&ValidationLifecycle

2、确认及验证生命周期RiskManagement风险管理Casestudies案例讨论FMEAofSterilizationProcess灭菌工艺FMEAFMEAofLyophillizationProcess冻干工艺FMEAFTAofTerminalSterilizedProduct最终灭菌产品故障树分析Conclusions结论GMP及验证Qualification&ValidationlifecycleRiskManagementCasestudiesFMEAofSterilizationProcessFMEAofLyophillizationProc

3、essFTAofTerminalSterilizedProductConclusionsCONTENT内容GMP和验证1972DEVENPORTINCIDENT(UK)英国德旺波特药难事件Infusionalsolutions,producedattheDevemportHospital,causedsixpatientdeceases.在英国德旺波特医院生产的输液，造成6个死亡病例TheROSENHEIMReportfoundthecausesinanotcorrectsterilizationtreatment.在ROSENHEIM报告中披露，原因是灭

4、菌不完全ExtractedfromtheROSENHEIMReport罗森海姆报告有以下内容TheAIRwasnotproperlyremovedfromthechamber没有适当去除空气Thedrainofthechamberwasblockedbypiecesofglasses排水管被玻璃堵塞Thelowersectionoftheloaddidnotreachthesterilizationtemperature低部位装载未达到灭菌温度Thetemperaturerecordershowedthisanomalybutpeoplethoughtit

5、wasnotworkingproperly温度记录有异常，以为是仪表问题Sterilitytestswerecarriedoutonlyontheupperlayersoftheload无菌检查只取了上部的样品GMP和验证Engineering–EquipmentImplications工程设计-设备方面Chapter3ofEU-GMP(PremisesandEquipment)欧盟GMP第3章（厂房及设备）21CFRpart211.63,211.65,211.67(Equipment)联邦法规211.63,211.65,211.67（设备）Annex11

6、–UEGMP(Computerisedsystems)欧盟附录11计算机系统21CFRpart211.68(Automatic,mechanicalandelectronicequipment)（自动化、机械及电气设备）21CFRpart11(Electronicrecords–ElectronicSignatures)联邦法规21第11部分（电子记录-电子签名）GAMP(GoodAutomatedManufacturingPractice)GAMP=优良自动化生产规范21CFRparts210-211(211.100,211.110,211.213)联邦

7、法规210-211(211.100,211.110,211.213)21CFRpart820(820.75)联邦法规820(820.75)EU–GMP(Cap.5.21–5.24)欧盟-GMP(Cap.5.21–5.24)EU–GMPAnnex15:(QualificationandValidation)欧盟-GMP(Cap.5.21–5.24)确认与验证CompliancePolicyGuideSec.490.100(ProcessValidationRequirementsforDrugProductsSubjecttoPre-MarketApprov

8、al)达标方针指南490.100节（药品批准前工艺验证要求）验证E