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1页共24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....................................................................................................................................................9Appendix2附录2.................................................................................................................................................12Appendix3附录3..................................................................................................................................................21第2页共24页HealthCanadaGoodManufacturingPracticesHealthProductsandFoodBranchInspectorateRiskClassificationofGMPObservations1.0PURPOSE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.Ajudgementbasedontheseobservationsisthenmadebytheinspectorandanoverallrecommendati...
