Lifting the Fog around the Visual Inspection of Injectable Products

《Lifting the Fog around the Visual Inspection of Injectable Products》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

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