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1、LiftinLiftinggtheFotheFoggaroundaroundtheVisualInspectionoftheVisualInspectionofInjectableProductsInjectableProductsJohnG.Shabushnig,Ph.D.PfizerGlobalQualityOperationsJuly23,2009CommonQuestionsCommonQuestions……??HowdoweassesstheriskthatparticlesmayHowdoweassesstheriskthatparticles
2、mayposetothepatient?posetothepatient???DoglassparticlesposeDoglassparticlesposeauniqueanddifferentauniqueanddifferentrisktopatients?risktopatients???WhatisaWhatisa““visiblevisible””particle?particle???WhatdoesWhatdoes““essentiallyfreeessentiallyfree””(USP)or(USP)or““practicallyfre
3、epracticallyfree””(EP)ofvisibleparticles(EP)ofvisibleparticlesmean?mean?MoreQuestionsMoreQuestions……??WhatistheappropriateWhatistheappropriateclassification(andclassification(andassociatedAQL)forparticles?associatedAQL)forparticles???HowdoweuseacceptancesamplinginaHowdoweuseaccept
4、ancesamplinginavisualinspectionprogram?visualinspectionprogram???IsautomatedinspectiIsautomatedinspectionbetterthanmanualonbetterthanmanualinspection?inspection???WhataretheregulatoryauthoritiessayingWhataretheregulatoryauthoritiessayingaboutinspection?aboutinspection?EvenMoreQues
5、tionsEvenMoreQuestions……??WhatdoweknowaboutindustryinspectionWhatdoweknowaboutindustryinspectionpractices?practices???WherecanIgetmoreinformation?WherecanIgetmoreinformation?HowdoweassesstheriskaparticleHowdoweassesstheriskaparticlemayposetoapatient?mayposetoapatient???ChemicalChe
6、mical--Single100umparticleinSingle100umparticlein1mLdoseisequivalent1mLdoseisequivalenttoanimpuritylevelof4ppm(v/v)toanimpuritylevelof4ppm(v/v)??MicrobiologicalMicrobiological--ParticlescanbecarriersformicrobiologicalParticlescanbecarriersformicrobiologicalcontaminationcontaminati
7、on??ProcessControlProcessControl--CosmeticassessmentofqualityCosmeticassessmentofquality??PhysiologicalPhysiologicalHowdoweassesstheriskaparticleHowdoweassesstheriskaparticlemayposestoapatient?mayposestoapatient???AnimalStudiesAnimalStudies-“Trulymassive”particledoses(e.g.105-109p
8、articles/kg/injection)-Usefulfors
