HACCP工艺风险评估报告模板.docx
RiskAssessmentReportforXXXProcessXXX工艺风险评估报告ReportApprovalJft告批准Company/Title公司/职务Name姓名Signature签名Date日期Writtenby编写Reviewedby审核Approvedby批准RevisionHistory版本修订索引ReV.版本Date口期RevisionReasons修订原因002022/10/30Initialissuance新制订Index目录1 OVerVieW概述42 Purpose目的43 SCOPe范围44 Responsibility职责45 AbbreViatiOnS缩略语66 RegulationandGuidance法规和指南67 SyStemDeSCriPtiOn系统描述87.1 PIantDeSCriPtiOn车间概述872ProdUCtlnformatiOn产品信息97.3 EqUiPmentS/SystemList设备/系统清单148 ReferenceDocuments参考文件159 RiskAssessmentMethod风f方法169.1 COndUCtaHaZardAnalySiS进行危害分析169.2 DeterminetheCriticalControlpoints(CCPS)关键控制点的确认199.3 EstablishTargetLevelsandCritiCaILJrnitS建立目标水平和关键限值199.4 EstablishSystem(s)tomonitoringCCP建立CCP监测系统209.5 EstablishanappropriateCorrectiveActionPIan建立适当的纠正计划209.6 EstablishProCedUreS建立规程219.7 EstablishDocumentationandkeeprecords建立文件并保留记录2110 HaZardanaIySiSMatriX危害分析矩阵2311 CCPContrOlMatriX关键控制点控制矩阵2412 CondUSion结论&建议251 Overview概述ThisdocumentsummarizesthequalityriskmanagementreportforXXXattheXXXsite.ThedocumentembracestheprinciplesofICHQ9(QualityRiskManagement)andusesriskmanagementtoolstosupportmanufacturingstrategiesdesignedtominimizeriskstoproductquality.本文件总结了位于XXX的XXX的质量风险管理报告。本文件包括ICHQ9(质量风险管理)的原则以及使用合适的风险管理工具来支持设计用于将对产品质量的风险降到最低的生产策略。AformalizedriskmanagementapproachwasappliedtotheXXXmanufacturingfacility.Thisinvolvedaholisticassessmentthatidentifiedthepotentialhazardsandriskstoproductqualityforallproductshandledinthefacilitytoensurethatappropriatecontrolswereinplacetomanufacturetheseproductssafely.Theassessmentsupportedthedevelopmentofaqualityriskmanagement(QRM)thataddressedthemanufactureofthefollowingproducts:XXX.对XXXXX生产工厂采用了一种正式化的风险管理方法。这涉及到能够确定对产品质量的可能危害和风险的全瞻性评估，以保证具有适宜的控制来以安全的方式生产这些产品。这种评估行为针对XXXX产品生产的质量风险管理(QRM)的制定提供了支持。2 Purpose目的Thepurposeofthisprocessriskassessmentistoevaluate,define,anddocumentallpotentialhazardandcriticalcontrolpointsforXXXProcessofOralDosagePlantofXXXbyapplyingtheprincipleofICHQ9(QualityRiskManagement)andriskmanagementtoolofHazardAnalysisandCriticalControlPoint(HACCP).Thisassessmentactivityistoensurethattheproductscanbemanufacturedunderappropriatecontrolandsafetymethod,andprovidesupporttodefineprocesscriticalcontrolpointsofXXXProcess.本工艺风险评估的目的是应用ICHQ9(质量风险管理)的原则以及使用危害分析和关键控制点(HACCP)的风险管理工具评估确定出XXX车间XXX生产工艺中所有的潜在危(wei)险和关键控制点，并记录在文件中。以保证具有适宜的控制，并以安全的方式生产该产品。这种评估行为针对XXX的生产工艺关键控制点的制定提供了支持。3 Spe范围TheriskassessmentscopeistheXXXXinXXXPlantofXXXX.TheProductCode:XXX.本工艺风险评估的范围为XXXX车间XXX,产品代码为XXX。4 Responsibility职责XXXresponsibilityXXX的职责：Riskassessmentexecution进行风险评估/RiskAssessmentReportcompilation风险评估报告的编写XXXresponsibilityXXX的职责：Toassurethatproduct-specificknowledgeandexpertiseareavailableforthedevelopmentofaneffectiveHACCPplanbyassemblingamultidisciplinaryteam.Teammembersshouldrepresentalltherelevantdisciplines,suchasresearchanddevelopment,production,qualitycontrol,qualityassurance,microbiology,engineeringanddistributionorothersasapplicablewiththeabilityto:确保具有产品的详细知识和专业技术，用以各专业组开辟有效地危害分析和关键工艺控制点的计划。小组成员应代表研发，生产，质量控制，质量保证，微生物学，工程和发货以及其他相关领域能力。/Conductahazardanalysis实施危害分析/Identifypotentialhazards识别潜在的危害/Identifyhazardswhichshouldbecontrolled识别应该控制的危害/Recommendcontrolsandcriticallimits建议的控制和关键限度/Deviseproceduresformonitoringandverification监测和确认的设计程序/Recommendappropriatecorrectiveactionwheredeviationsoccur对发生的偏差推荐合适的纠正措施/EstablishDocumentationandkeeprecords建立文件并保留记录/VerifytheHACCPplan确认危害分析和关键控制点计划Otherresponsibilities:其它职责/Informationcollection信息的采集/Supplyallprocedure,data,manuals,drawinganddocumentationnecessaryforthecompletionoffinalreport提供为报告编写所需要的所有的规程、数据、手册、图纸和文件JTakingpartintheRA参预风险评估/Reviewandapprovethereport报告的审核和批准5 Abbreviations缩略语Theabbreviationswhichwillbeusedinthisdocumentarelistedinthefollowingform.在下面的表格中规定了本文件中使用的缩略语。Abbreviations缩略语Definition定义CCPCriticalControlPoints关键控制点EUEuropeanUnion欧洲联盟GMPGoodManufacturingPractice药品生产质量管理规范HACCPHazardAnalysisandCriticalControlPoint危害分析与关键控制点ICHInternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse人用药品注册技术要求国际协调会ISPEInternationalSocietyforProductivityEnhancement国际制药工程协会PQPerformanceQualification性能确认PVProcessValidation工艺验证QRMQualityRiskManagement质量风险管理RARiskAssessment风险评估SFDAStateFoodandDrugAdministration国家食品药品管理局SIASystemImpactAssessment系统影响评估SOPStandardOperatingProcedure标准操作程序URSUserRequirementsSpecification用户需求说明6 RegulationandGuidance法规和指南Towritethisprotocolthefollowingreferencedocumentshavebeenused:为了编写本报告，参考了以下法规和指南：/StateFoodandDrugAdministration(CFDA),China,GoodManufacturingPractice(2022Revision）,March,2022国家食品药品监督管理局（CFDA）,中国，药品生产质量管理规范（2022年修订），2022年03月/ICHQ9:QualityRiskManagementICHQ9：质量风险管理，2005年11月/ISPEGuidelineVolume5,Com
