验证主计划、设备、设施、工艺、清洗等验证Validation_and_Qual

题目题目„„验证主计划验证主计划ValidationMasterPlanValidationMasterPlan„„设备验证设备验证EquipmentvalidationEquipmentvalidation„„设施设施(HVAC,(HVAC,水水))验证验证Facilities(HVAC,Facilities(HVAC,water)water)validationvalidation„„工艺验证工艺验证ProcessvalidationProcessvalidation„„清洗验证清洗验证CleaningvalidationCleaningvalidation验证定义验证定义DefinitionofValidationDefinitionofValidation„„ValidationValidationisestablishingisestablishingdocumentedevidencedocumentedevidencewhichprovidesawhichprovidesahighdegreeofassurancehighdegreeofassurancethatathataspecificprocesswillspecificprocesswillconsistentlyproduceconsistentlyproduceaproductaproductmeetingitsmeetingitspredeterminedpredeterminedspecificationsandqualityspecificationsandqualitycharacteristics.characteristics.““GuidanceonGeneralPrinciplesofProcessValidationGuidanceonGeneralPrinciplesofProcessValidation””..OfficeofCompliance,CDER,FDA,May1987OfficeofCompliance,CDER,FDA,May1987联邦法规联邦法规21CFR211.110(a)21CFR211.110(a)……writtenproceduresshallbeestablishedandwrittenproceduresshallbeestablishedandfollowedthatdescribetheinfollowedthatdescribethein--processcontrols,processcontrols,andtests,orexaminationstobeconductedonandtests,orexaminationstobeconductedonappropriatesamplesofinappropriatesamplesofin--processmaterialsofprocessmaterialsofeachbatch.Suchcontrolproceduresshallbeeachbatch.Suchcontrolproceduresshallbeestablishedtomonitortheoutputandestablishedtomonitortheoutputandtovalidatetovalidatetheperformanceofthosemanufacturingprocesstheperformanceofthosemanufacturingprocessthatmaythatmayberesponsibleforcausingvariabilityberesponsibleforcausingvariability……ValidationMasterPlanValidationMasterPlan(VMP)(VMP)验证总计划验证总计划VMPVMP验证总计划验证总计划„„验证主计划验证主计划(VMP)(VMP)是一个纲领性的文件，是一个纲领性的文件，它描述一个设它描述一个设施，仪器，设备，工艺，厂区的验证施，仪器，设备，工艺，厂区的验证,,提供达到这些要求提供达到这些要求的计划。的计划。AValidationMasterPlan(VMP)isacomprehensivedocumentdescrAValidationMasterPlan(VMP)isacomprehensivedocumentdescribingtheibingtheapplicablevalidationrequirementsforafacility,and/orasystapplicablevalidationrequirementsforafacility,and/orasystem,and/oraproduct,em,and/oraproduct,andprovidingaplanformeetingthoserequirements.andprovidingaplanformeetingthoserequirements.„„验证主计划是验证的路线图，提供各步骤的顺序直至验收验证主计划是验证的路线图，提供各步骤的顺序直至验收和审计。和审计。TheVMPprovidesaTheVMPprovidesa““roadmaproadmap””forvalidation,toestablishasequenceofeventsforvalidation,toestablishasequenceofeventsfollowedbyfacilityauditsandinspectionsfollowedbyfacilityauditsandinspections„„验证主计划验证主计划包括药品生产过程中的所有的有关的领域包括药品生产过程中的所有的有关的领域TheValidationMasterPlan(VMP)includesallrelevantaspectsrTheValidationMasterPlan(VMP)includesallrelevantaspectsrelatingtotheelatingtotheproductionofpharmaceuticalsintheproductionfacility.productionofpharmaceuticalsintheproductionfacility.VMPVMP验证总计划验证总计划„„验证工作起始于原材料及组件的设计开发，然后是厂房，验证工作起始于原材料及组件的设计开发，然后是厂房，设备，体系的设备，体系的IQ/OQIQ/OQ/PQ/PQ，结束于正式的生产工艺验证，结束于正式的生产工艺验证ThevalidationprogramstartswiththedesignanddevelopmentThevalidationprogramstartswiththedesignanddevelopmentofrawmaterialsandcomponents,followedbytheIQ/OQofofrawmaterialsandcomponents,followedbytheIQ/OQoffacilities,equipment,andsystemsthroughperformanceandfacilities,equipment,andsystemsthroughperformanceandprocessqualificationstages,andterminatesintheprotocolprocessqualificationstages,andterminatesintheprotocol--driven,threedriven,three--batch,formalprocessvalidationprogram.batch,formalprocessvalidationprogram.„„虽然大多数的验证工作是串联式的安排，但如果能将某些虽然大多数的验证工作是串联式的安排，但如果能将某些工作平行进行，会节省时间，加速验证工作进度工作平行进行，会节省时间，加速验证工作进度Mostoftheseactivitiescanbemovedforwardinseries.Mostoftheseactivitiescanbemovedforwardinseries.However,bycombiningactivitiesandelementsandmovinginHowever,bycombiningactivitiesandelementsandmovinginparallel,agreatdealoftimecanbesaved.parallel,agreatdealoftimecanbesaved.VMPVMP验证总计划验证总计划验证主计划应包括以下各项：验证主计划应包括以下各项：VMPshouldcover,butnotVMPshouldcover,butnotlimitto,thefollowingactivities:limitto,thefollowingactivities:„„设施验证设施验证（厂房，车间等）以及配套设施（（厂房，车间等）以及配套设施（HVAC,HVAC,水水系统等）系统等）QualificationoffacilitiesQualificationoffacilities(plant,workshop,etc)(plant,workshop,etc)andandsupplysystems(HVAC,water,etc.)supplysystems(HVAC,water,etc.)„„仪器设备验证仪器设备验证(DQ,IQ,OQ,PQ)Qualificationof(DQ,IQ,OQ,PQ)Qualificationofequipment(DQ,IQ,equipment(DQ,IQ,OQ,PQ)OQ,PQ)„„计算机体系验证计算机体系验证ValidationofcomputersystemsValidationofcomputersystems„„生产工艺验证生产工艺验证ValidationofproductionprocessesValidationofproductionprocesses„„清洗验证清洗验证ValidationofcleaningprocessesValidationofcleaningprocesses„„分析方法验证分析方法验证ValidationofanalyticalmethodsValidationofanalyticalmethods„„再验证和变更控制再验证和变更控制PeriodicrevalidationwithinthescopeofPeriodicrevalidationwithinthescopeofachangecontrolplanachangecontrolplan验证小组成员验证小组成员ValidationTeamMembersValidationTeamMembers„„验证小组要包括以下成员验证小组要包括以下成员ThevalidationteamshouldbeThevalidationteamshouldbeconsistofthefollowingrepresentativemembers:consistofthefollowingrepresentativemembers:„„质保质保QualityAssuranceDepartmentQualityAssuranceDepartment„„质检质检QualityControlLaboratoryQualityControlLaboratory„„工程部工程部Engineering(Utilities)Engineering(Utilities)„„设备校验和维护设备校验和维护EquipmentCalibration/MaintenanceEquipmentCal