诺华清洗要求课件.ppt

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1、CleaningValidationforMultipurposePlant/EquipmentWhyCleaningValidationhastobeperformed?MultipurposePlantinChinaMainGuidlinesandSOPsforCleaningValidationApproachestoCleaningValidationCriteriaforWorstCaseSelectionChallengeMultipurposePlantsPrerequisitesGeneralCleaningProcedureSamplingCleaningLimitsC

2、alculationofCleaningLimitsRevalidation2WhyCleaningValidationhastobeperformed?PIC/SPI006-2:7.1.1:...activepharmaceuticalingrediants(APIs)canbecontaminatedbyother....APIs,bycleaningagents,bymicro-organismsorbyothermaterial(e.g.air.borneparticles,dust,lubricants,rawmaterials,intermediats,...).Inmanyc

3、asesthesameequipmentmaybeusedforprocessingdifferentproducts.Toavoidcontamination...adequatecleaningprocedureareessential.7.1.3:CleaningValdiationisthedocumentedevidencethatanapprovedcleaningprocedurewillprovideequipmentwhichissuitableforprocessingofpharmaceuticalproductsoractivepharmaceuticalingre

4、diants(APIs)7.1.4:ObjectiveoftheCleaningValidationistheconfirmationofareliablecleaningproceduresothattheanalyticalmonitoringmaybeomittedorreducedtoaminimumintheroutinephase.3MultipurposePlantinChinaIntheChineseAPIChemicalIndustry,mainlydedicatedplantsareinplaceandthemultipurposeconceptisnotyetesta

5、blished.Onlysince200xxxxintroducedthemultipurposeconceptfor4productionbuildings:---Multipurpose2xx:2APIs(3APIs2008)---Multipurpose2xx:2Intermediates---Multipurpose3xx(x):2Intermediates---Multipurpose2xx(Future):2Intermediates4CleaningValidationMainGuidelinesandSOPsforCleaningValidation5CleaningVal

6、idationhastobeperformed,if….6CleaningValidationApproachestoCleaningValidationFormultipurposeequipment,cleaningvalidationwillbeperformedbasedonaworstcaseconceptEachProductionUnithasadifferentintermediateandAPImix=>differentgroupingandworstcaseselectionFordedicatedequipmentcleaningvalidationislimite

7、dtotheremovalofdetergents*,disinfectants*andpreventionofmicrobiologicalcontamination.*Incasedetergentsanddisinfectantsareused.7CleaningValidationCriteriaforworstcaseselectionThemaincriterionfortheassessmentisthes