药品生产企业GMP验证培训(巴斯德2)_管理机构对制药企业检查展望

2019/12/181THEPHARMACEUTICALINDUSTRIESEXPECTATIONSOFINSPECTIONSBYREGULATORYAUTHORITIES管理机构对制药企业认证检查展望DavidCDonaldGlobalIndustrialQualityInternationalSites2019/12/182TheExpertiseoftheInspectors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2019/12/183TheRoleoftheInspectors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GMPIdentifydeficienciesinGMP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2019/12/184RegulatoryInspectionPreparation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(PAI’s)批准前检查LicenceVariations;AdverseEventsetc许可证变更，不良反应事件2019/12/185TypesofInspection检查类型1.RoutineManufacturer’sInspection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2019/12/186TypesofInspection检查类型2.Follow-upInspection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.ProductRelatedInspection与制品相关的检查-toassesscomplianceoftheManufacturers’operationswiththedetailsintheProductLicence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2019/12/187TypesofInspection检查类型4.SpecialistInspections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-biologicalinspectionsusespecialistprincipalinspectorstoevaluatespecificaspectsmicrobiologicalaspectswatersystemsetc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2019/12/188TypesofInspection检查类型5.WholesaleDealers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.ContractLaboratories委托检测的实验室-inspectedtoassesscompliancewithGoodLaboratoryPracticeStandardsandconfirmthattherelevantprovisionsofthelicenceareobservedfortheproductswhicharetested.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2019/12/189QualitySystems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2019/12/1810FrequencyofInspections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«Marginal»companies:12–18months〈边缘〉企业：12-18个月Follow-up:within6months跟踪相查：6个月内Overseassites:2–3years海外基地：2-3年2019/12/1811DurationofInspections检查持续时间ProductManufactureSuper+250staffLarge60–249staffMedium10–59staffSmallLessthan10staffSterile10632NonSterile8321Assembly7112019/12/1812PreparationforInspection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Licensedmatters–licensesheld,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2019/12/1813PreparationforInspection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2019/12/1814PreparationforInspection检查的准备工作ReviewtheCompany’sQualityPolicyandarrangementsformonitoringthequalitysystem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2019/12/1815On-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2019/12/1816On-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Itisimportanttomention«plus»points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2019/12/1817On-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