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2024/7/201THEPHARMACEUTICALINDUSTRIESEXPECTATIONSOFINSPECTIONSBYREGULATORYAUTHORITIES管理机构对制药企业认证检查展望DavidCDonaldGlobalIndustrialQualityInternationalSites2024/7/202TheExpertiseoftheInspectors检查员的专业技术Inspectorsshouldhaveprevioustrainingandpracticalexperienceinmanufacture,qualitycontrolandqualityassuranceofpharmaceuticalproducts检查员须经培训及具有制药企业生产，质控及质保等方面的实际工作经验Deficienciesinexperienceneedsin-housetraining;attendanceatcourses;seminars经验上的不足需要加强内部培训，上课及参加研讨会Athoroughknowledgeisneededinaspectsofthepharmaceuticalindustry完整的业内知识需涉及制药行业的所有领域2024/7/203TheRoleoftheInspectors检查员的任务PrimeresponsibilitytoproduceafactualreportonthestandardsofGoodManufacturingPractice(GMP)主要职责是以GMP为标准书写一份反映实际情况的报告AssistManufacturerstocomplywithGMP帮助企业更好地执行GMPIdentifydeficienciesinGMP鉴定GMP执行过程中的缺陷Giveadviceonwaystocorrectdeficiencies对纠正缺陷的方法提出指导Acceptalternativewaysofcompliance接受与GMP要求相符的其他选择方法2024/7/204RegulatoryInspectionPreparation准备检查Theplanning,organisation,methodofworkingandformatofthefinalreportisdeterminedbytheobjectiveoftheinspection在检查目的中应明确检查计划，组织，工作方法和报告的格式制定InspectionsofManufacturers生产企业的检查Formulation,FillingandPackagingOperations配方，分包装操作ContractTestingLaboratories委托检测的实验室BloodProducts血制品Pre-ApprovalInspections(PAIs)批准前检查LicenceVariations;AdverseEventsetc许可证变更，不良反应事件2024/7/205TypesofInspection检查类型1.Routine Manufacturers Inspection常规生产企业的检查-AninspectiontosatisfythelicensingauthoritythatthemanufacturerisincompliancewithhislicenceandmeetstheGMPrequirements对生产企业许可证的检查以确认该证的符合度及是否与GMP要求相一致-fornewlyestablishedfacilities对新建设施的检查-newproductlines对新建生产线的检查-changesinkeypersonnelorequipment对主要人员或设备变更的检查2024/7/206TypesofInspection检查类型2.Follow-up Inspection跟踪检查-thefirstinspectionisincomplete第一次检查不彻底-theCompanyhasmajordeficiencies发现企业存在严重缺陷3.Product Related Inspection与制品相关的检查-toassesscomplianceoftheManufacturersoperationswiththedetailsintheProductLicence确认企业运作与产品许可证具体要求是否相符-eitherprimepurposeorpartofGMPinspection可以是检查的首要目的，也可以是检查的一部分2024/7/207TypesofInspection检查类型4.Specialist Inspections专家检查-BulkproductionofBiologicalProductsandBloodProductsusespecialistbiologicalinspectors生产制品原液生产和血制品须由生物学方面的专家进行-Non-biologicalinspectionsusespecialistprincipalinspectorstoevaluatespecificaspectsmicrobiologicalaspectswatersystemsetc非生物学专家组成的检查应由主要检查人员评估专业性的问题：如微生物学方面的问题，水系统方面的问题2024/7/208TypesofInspection检查类型5.Wholesale Dealers批发商-toassesscompliancewithgoodwholesaledealingpracticeandprovisionsofthelicence评估批发商运作行为是否规范，所提供的许可证是否与实际相符-ImportDealerslicencewitharrangementsforquarantine,QCandfinalreleaseofimportedproducts进口批发商许可证及与待检，QC，进口产品的最终发放的安排等6.Contract Laboratories委托检测的实验室-inspectedtoassesscompliancewithGoodLaboratoryPracticeStandardsandconfirmthattherelevantprovisionsofthelicenceare observedfortheproductswhicharetested.检查以评估GLP的执行情况，并确认执照上所述提供的用以产品检测的相关设施2024/7/209QualitySystems质量系统TheCompanyOrganization公司组织QualityGroup质量保证群体Procedures程序ManufacturingProcess生产工艺Records记录QualityControl质控QAactivitiescarriedout贯彻执行的质量保证2024/7/2010FrequencyofInspections检查频率ManufacturersLicence:2years生产许可企业：2年WholesaleDealerImportLicence:2years进口产品批发商：2年WholesaleDealerLicenceHolder:4years批发商营业执照持有人：4年Marginalcompanies:1218months边缘企业：12-18个月Follow-up:within6months跟踪相查：6个月内Overseassites:23years海外基地：2-3年2024/7/2011DurationofInspections检查持续时间ProductManufactureSuper+250 staffLarge60 249staffMedium10 59staffSmallLess than 10 staffSterile10632Non Sterile8321Assembly7 112024/7/2012PreparationforInspection检查的准备工作ReviewtheCompanyfile审核企业文件Previousreportsandresponses以前的检查报告及反馈Anyfollow-upaction任何跟进措施ReviewofSiteMasterFile审核企业自述性文件Licensedmatterslicensesheld,operatingsites,authorisedstaff,limitationsimposedbyspecificprovisions,authorisedproducts有关许可证事宜：所持许可证，生产基地，授权员工，特殊产品带来的局限性2024/7/2013PreparationforInspection检查的准备工作Agreethetimeofthepostinspectionmeeting同意检查后会议的时间Describeitspurpose目的描述Summarizethewaythedeficienciesaretobeclassified概述缺陷的分类方式Indicateanydocumentationrequired指出所需的任何文件ReviewManagementstructure审核管理框架2024/7/2014PreparationforInspection检查的准备工作ReviewtheCompanysQualityPolicyandarrangementsfor monitoringthequalitysystem审核公司质量政策及质量系统监控的安排ReviewChanges审核变更情况Reviewprogresswithdeficiencies审核缺陷的跟进工作2024/7/2015On-SiteInspection现场检查WalkthroughtheSite走一遍厂区InspecttodeterminethedegreeofconformityoftheoperationstotherequirementsofGMPandcompliancewiththelicenceanddetailsintheapplication检查确定实际运作与GMP要求的符合程度及实际运用与许可证要求的一致性Itinerarydeterminedbythetypeofinspection确定检查路线2024/7/2016On-SiteInspection现场检查Theinspectionshouldfollowalogicalsequence检查应按一定的逻辑顺序Observations,recommendationsanddeficienciesshouldbediscussedwiththecompanyrepresentativesatthetime发现的不到之处，建议和缺陷应与及时与厂房代表沟通Itisimportanttomentionpluspoints提及附加项这点很重要Followtheplanasfaraspossible尽可能多地按计划进行TheinspectionisbasedonObservations 检查要基于观察观察2024/7/2017On-SiteInspection现场检查Inspectorsmayuseachecklisttoensureallareasofoperationsareinvestigated检查员可以使用检查表来确认所有区域均列入ExperiencehasshownthatrigidadherencetoaverydetailedchecklistdevelopedfromGMPGuidelinescanleadtomissingvulnerableareas经验告诉人们严格按照根据GMP指南上套用下的明细表来检查会错过一些簿弱环节Inspectorsshouldnotbeconcernedwithnon-GMPaspectsegfinance,H&S检查员不应关心与GMP无关的事宜，例如：财务，H&S2024/7/2018On-SiteInspection现场检查MedicinesTestingScheme:Inspectorssamples医学试验计划：检查员样品Duringinspectionssamplesofstartingmaterials,workinprogressand finishedproductcanbetakenfortestingiftheInspectorconsidersthatitmightassistinthedetectionofqualitydeficiencies检查过程中，如果检查员认为可能对判断质量缺陷有帮助，则应取原材料样品、过程中样及成品来做试验DocumentationReview文件审核Anessentialpartoftheinspection.检查的实质部分Thisisthehistoricalevidenceofcompliance这是说明过往符合要求的依据Documentscanbereviewedduringthecourseofthesiteinspectionandindetailinthemeetingroom在现场检查阶段应审核文件，在会议室更深入了解2024/7/2019DocumentReview文件审核Manufacturingformulae生产配方BatchManufacturingRecords批记录Specifications技术规格chemicalrawmaterials化学原材料packagingcomponents包装村料intermediates中间产物finishedproducts成品2024/7/2020DocumentReview文件审核Processandequipmentvalidation工艺及设备验证Environmentalmonitoring环境监控StandardOperatingProcedures标准操作规程Trainingrecords:jobdescriptions培训记录：工作职责描述Releaseprocedures发放程序DistributionandRecall发货及召回TechnicalAgreements技术协议2024/7/2021QualityIndicators质量显示器CustomerComplaintsQuantity,Investigation,PreventiveAction用户投诉记录数量，调查，防范措施ProductRecallsdefectsreportedtothecompanyortotheDefectReportingCentreandanyrecallsinstitutedsincethepreviousinspectionshouldbediscussedandrecordsexamined产品召回报告至企业或报告中心的过失及任何自上次检查以来已经展开调查的召回案件都要进行讨论并检查记录HandlingofReturns退货的处理2024/7/2022QualityIndicators质量显示器Self-Inspectionreportsobtainassurancethatinternalauditsare conductedandfollow-upactionistaken.自查报告确认企业执行内部自查并采取相关跟进措施。Note:Asamatterofpolicytheinternalauditsshouldnotberead作为一项政策，不应过目内部自查报告Non-conformanceprocedure异常情况程序ChangeControlProcedure变更控制程序2024/7/2023ClosingMeeting结束会议InspectorconvenesameetingwiththeCompanyRepresentatives检查员召集企业代表开会SummarisetheproposedlistofdeficienciestoreporttotheLicensingAuthority总结汇集的缺陷上报有关机构AllowCompanytocorrectmisconceptions允许企业更正误解Bereadytoexplainyourreasons准备作出自已的解释Usefultodiscusspossibleremedialactions讨论可能的补救措施是有用的2024/7/2024ClosingMeeting结束会议TheCompanyshouldbeencouragedtogiveanundertakingtoresolvethedeficienciesandtoagreeaprovisionaltimetableforcorrectiveaction.应鼓励企业承诺拿出针对这些缺陷的处理方案及纠偏行动的时间表TheReportisin3parts:-报告包括3部份内容i)InspectorsInformation检查员信息ii)SummaryandConclusions总结及结论iii)TheCompanySiteMasterFile企业自述性文件2024/7/2025REPORT报告Inspectors information检查员信息Inspectorssummarysheetandintroduction检查员概述及介绍Briefreportofinspectionactivities检查活动的大体报告Scopeoftheinspection检查范畴Personnelmet已会见人员Changessincepreviousinspection上次检查后的变化情况Futureplannedchanges以后计划的变化情况2024/7/2026REPORT报告i)Inspectors information检查员信息Inspectorsfindings检查员发现的情况Samplestakenandresultsifknown所取的样品及已知的结果Assessmentofthesitemasterfile对自述性文件的评估GMPrelatedrecallsmadeinthelast2years在最近2年内与GMP相关的召回案件2024/7/2027REPORT报告ii)Summary and conclusions总结与结论ThelistoffailurestocomplywiththeEuropeanGuidetoGoodManufacturingPracticeswithreferencetotheappropriatesectionoftheguide.列表陈述与欧洲GMP指南不相符合的事项及相关参照条例iii)The Company Site Master File公司自公司自述性文件述性文件Theneed,ifany,toupdatetheCompanySiteMasterFileinlightoftheInspection.按检查结果是可否更新公司自述性文件2024/7/2028FinalRemarks最后评论Points for the Inspector to consider检查员要考虑的几点内容Theconditionofthefacilities厂房的条件Thecleanlinessofthefacilities厂房的洁净度Theorganisation人员机构组成Thestaffattitude/professionalism员工的敬业程度及专业水平Thesitepreparationfortheinspection检查的准备Thesystematicwayofworking工作的系统方式2024/7/2029FinalRemarks最后评论The integrity of the site QA staff QA员工的正直程度Consider考虑SiteQAworkforthePatient工厂QA的工作是站在患者立场上SiteQAworkfortheRegulatoryAuthority工厂QA的工作对有关当局负责SiteQAworkfortheCompany工厂的QA为企业工作TheInspectormustmakeajudgementoftheCompanieslevelofCOMPLIANCE.检查员应对企业与GMP符合度作出判断The?:canthecompanymakemedicinesfitforhumanuse?企业是否够格生产人用药品Answer:Yes是:Yeswithreservations是，但有保留:No不2024/7/2030FinalRemarks最后评论ThisdecisionontheCompanieslevelofcompliancecannotbetakenlightly.决定不要轻易下Thesafetyofthepatientisparamount患者的安全是很重要的However,failingsafeisnotanoption然而，失去安全性不是一个选择Simplyrefusingallapplicationsdeprivesthepatientoflifeimprovingmedicines以损失患者的生命为代价来改进药品是万不足取的Abusinesscanbeunnecessarilydestroyed事业可以被没有必要地破坏掉TheroleofanInspectorisnotanEASYONE检查员的工作不是一项容易的事后面内容直接删除就行后面内容直接删除就行资料可以编辑修改使用资料可以编辑修改使用资料可以编辑修改使用资料可以编辑修改使用资料仅供参考，实际情况实际分资料仅供参考，实际情况实际分析析主要经营：主要经营：课件设计，文档制作，课件设计，文档制作，网络软件设网络软件设计、图文设计制作、发布广告等计、图文设计制作、发布广告等秉着以优质的服务对待每一位客户，做到让客秉着以优质的服务对待每一位客户，做到让客户满意！户满意！致力于数据挖掘，合同简历、论文写作、致力于数据挖掘，合同简历、论文写作、PPT设计、计划书、策划案、学习课件、各类模板设计、计划书、策划案、学习课件、各类模板等方方面面，打造全网一站式需求等方方面面，打造全网一站式需求The user can demonstrate on a projector or computer,or print the The user can demonstrate on a projector or computer,or print the presentation and make it into a film to be used in a wider fieldpresentation and make it into a film to be used in a wider field
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