欧盟对灭菌技术的要求

《欧盟对灭菌技术的要求》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、欧盟对灭菌技术的要求SterilisationTechnology–EURegulatoryExperiencesthecompliancegroupStanO’NeillCPAPE2011年会Agenda内容Background背景TypicalProcessdescription典型工艺的描述Virtualinspection–typicalissues我们来作一次虚拟的检查–看常见的问题Miscellaneous其它Background背景ExperienceinindustryinRegAffairsandQA(asQP)prior

2、toIMB在进爱尔兰药品管理局前，有制药、法规与QA(QP)的经验10YearsIMB,experienceinmosttechnologies,EMEAIWG,andtraining.爱尔兰药品管理局10年，有多种技术、EMEAIWG以及培训方面的经验Nowa“virtualinspector”现在是“事实上的检查员”Soletsdoa“virtualinspection”好，我们来做当一回“检查员”Butletstalkaboutthesolutions/strategies/positions;notjusttheproblems.我们

3、先来讨论战略位置/策略/解决方案，而不只是讨论问题Typicalprocess典型工艺Rawmaterialsampling原料取样Materialsdispensed物料配制Rawmaterialsmixed原料混合Bulkproductfiltered已过滤的药液Productfilled已灌装产品Bulkproductstored药液储存Unitssealed密封产品Unitsstoppered已加塞产品Unitsinspected已检查品Qualitycontrol质量控制Sealedunitsterminallysterilised

4、密封产品最终灭菌Colourcodingsystem彩色编码系统Processingsteps操作步骤Aseptic无菌操作TerminallySterilized最终灭菌Problem问题Solution解决方案Ancillarysteps辅助步骤ProcessingstepsAsepticTerminallySterilizedProblemSolutionAncillarystepsRawmaterialsamplingIdentitytestingofeachcontainerofAPIandexcipientsValidatedNI

5、RacceptableoneachcontainerwithMAidentitytestoncompositeClassificationandgarbingforsamplingareaGradeC(equivalentactivitytocompounding).Nooutdoorclothing.MaterialsdispensedClassificationandgarbingfordispensingareaGradeC(equivalentactivitytocompounding).Nooutdoorclothing.Sampl

6、ing&identification加工步骤无菌操作最终灭菌问题解决方案辅助操作原料取样对每个容器的原料药与辅料进行鉴别实验可用经验证的近红外，在生产现场对组份作每个容器的鉴别试验取样区级别与着装C级区(与配制活动同级)，不穿室外衣服物料称量配料区级别与着装C级区(与配制活动同级)，不穿室外衣服原料鉴别ProcessingstepsAsepticTerminallySterilisedProblemSolutionAncillarystepsRawmaterialsmixedBulkproductfilteredWeepingsealbetw

7、eencleanandnon-cleansideofmixingshaftUnderstandingthesystem,ensuringweepingfluidisWFI.Pre-use,poststerilizationintegritytestThetestshouldbeperformed,asconfirmedbytheEMEA.Numeroustechnicalsolutionsarepossible.TandPnotindependentofcontrolsystemsConsiderintroductionofindepende

8、ntmonitoringsystem.Ataminimum,apressuregaugeperiodicallychecked.Sterilizationofequ