加拿大GMP检查风险分级

第1页共25页HealthProductsandFoodBranchInspectorate食品与健康类产品检查员Guide-0023指南-0023RiskClassificationofGMPObservations,2003editionGMP检查发现的风险分级，2003版Supersedes:June1st,2000editionDateissued:April4th,2003Dateofimplementation:June1st,2003Cedocumentestaussidisponibleenfrançais.本文可提供法语版第2页共25页TABLEOFCONTENTS目录1.0PURPOSE目的........................................................................................................................................32.0BACKGROUND背景.............................................................................................................................33.0SCOPE范围.............................................................................................................................................34.0DEFINITIONS定义:...............................................................................................................................45.0GUIDE指南正文.....................................................................................................................................65.1Assignmentoftherisktoanobservation针对缺陷界定风险.............................................................65.2Assignmentoftheinspectionrating检查评定.....................................................................................75.2.1Risk1observation:1类风险缺陷.............................................................................................75.2.2Risk2observation:2类风险缺陷.............................................................................................75.2.3Risk3observations:3类风险缺陷...........................................................................................85.3Additionalguidance补充........................................................................................................................8Appendix1附录1..................................................................................................................................................10Appendix2附录2.................................................................................................................................................13Appendix3附录3..................................................................................................................................................22HealthCanadaGoodManufacturingPracticesHealthProductsandFoodBranchInspectorateRiskClassificationofGMPObservations第3页共25页1.0PURPOSE目的Toclassifytheobservationsnotedduringestablishmentinspectionsaccordingtotheirrisk.依据风险的程度对企业检查中的发现进行分级。ToensureuniformityamongtheinspectorsoftheHealthProductsandFoodBranchInspectorate(theInspectorate)intheattributionoftheratingfollowingestablishmentinspections.确保食品与健康产品检查员（检查员）在对企业进行评估时采用统一的标准。ToinformtheindustryofthesituationsthattheInspectorateconsidersunacceptableandthatwillgenerateaNonCompliant(NC)ratingfollowinganinspection.将各种不被检察员接受进而导致认证失败的情况明确告知企业。2.0BACKGROUND背景Duringanestablishmentinspection,deviationsfromtheFoodandDrugRegulationsandthecurrenteditionoftheGoodManufacturingPractices(GMP)guidelinesarenotedbytheinspectorandthesedeviationsappearasobservationsintheinspectionexitnotice.Ajudgementbasedontheseobservationsisthenmadebytheinspectorandanoverallrecommendationforthecontinuationorissuanceoftheestablishmentlicence(ratingofCompliance)ornottocontinueorissuethelicence(ratingofNon-Compliance)isgiven.AttributionofaNCratingmayhaveseriousconsequencesforacompany,rangingfromtheimplementationofimportantcorrectivemeasurestothetemporarysuspensionorterminationoftheEstablishmentLicence(EL).Therefore,thesesituationsofnon-conformityhavetobewelldefined,unambiguousanddirectlysupportedbytheapplicableregulations.在工厂检查时，凡违反食品药品法和现行GMP的行为都将被检察员记录下来作为离开时检查通告中的检查缺陷。基于这些缺陷，检查人员将做出判断并对是否应该授予或延续企业许可证（合规评定）或不授予或取消企业许可证（不合规评定）给出综合性意见。得到不合规评定有可能给企业带来严重的后果，包括停业整顿或吊销执照。因此，所有不合规的界定应有清晰明确的定义并有章可循。3.0SCOPE范围ThedefinitionofadruginCanadacoversawidevarietyofproductsrangingfrompharmaceuticalsandbiologicstonaturalhealthproductssuchashomeopathicsandherbalpreparations.ThisguidancedocumentcoversallsuchproductstowhichDivision2ofPartCoftheFoodandDrugRegulationsappliesandisbasedonthecurrenteditionoftheGMPGuidelines.ItisrecognisedthattheevaluationoftheconformitytotheGMPshouldbecommensuratewiththeriskinvolvedtakingintoaccountthenatureandextentofthedeviationinrelationwiththecategoryofproductsevaluated.Nonetheless,mostofthesituationsinvolvingfraud,misrepresentationorfalsificationofproductsordatawillgenerateaNCrating,irrespectiveofthecategoryofproductsinvolved.HealthCanadaGoodManufacturingPracticesHealthProductsandFoodBranchInspectorateRiskClassificationofGMPObservations第4页共25页在加拿大，药品定义广泛，从生化药物到自然的健康产品如顺势疗法和草药都属于此范畴。本文依照现行GMP制定，适用于所有食品药品法C部第2章节所规定的产品。GMP合规评估和风险评估是同时进行的，而风险评估需要根据缺陷的性质与程度同时与评估产品的类别联系起来，这些都已得到业界的认同。但是，大多数导致认证失败的发现如产品或数据存在虚假，歪曲或蓄意伪造都没有考虑产品的类别。Theappendicesattachedtothepresentdocumentdescribetheobservationsrelatedtoeachcategoryofrisk.Pleasenotethatthelistofobservationsineachappendixisnotexhaustiveandthatadditionalobservationsmaybeaddedwhereappropriate.本文附录描述了检查发现相应的风险级别。请注意附录中并未完全列举所有的检查发现，需要之处可以补充。The