SMF编写指导原则
GuidelinesfordraftingaSiteMasterFile(SMF)
Asitemasterfileshouldbesuccinctand,asfaraspossible,notexceed25A4pages.
现场主文件应尽可能简短明了，不能超过25页A4纸
LayoutoftheSMF:现场主文件设计
Frontpage封面
Tableofcontents目录
Contents:内容
1.Generalinformation概述
1.1Briefinformationonthefirm(includingnameandaddress),relationtoothersites,and,inparticular,anyinformationrelevanttounderstandingthemanufacturingoperations.关于企业(包括名称和地址)的简要描述,包括其他与生产有关的内容。
1.2Pharmaceuticalmanufacturingactivitiesaslicensedbythenationalauthority.政府机关允许的药品生产活动
1.3Anyothermanufacturingactivitiescarriedoutonthesite现场其他生产活动
1.4Nameandexactaddressofthesite,includingtelephone,fax,and24-hourtelephonenumbers.详细的地址，以及电话、传真、24小时电话
1.5Typeofproductsmanufacturedonthesite,andinformationaboutanyspecificallytoxicorhazardoussubstanceshandled,mentioningthewaytheyaremanufactured(indedicatedfacilitiesoronacampaignbasis).现场生产的产品类型及对有毒有害物质的处理方法
1.6Shortdescriptionofthesite(size,location,andimmediateenvironmentandothermanufacturingactivitiesonthesite).厂区位置、面积及周围环境的描述
1.7Numberofemployeesengagedinproduction,qualitycontrol,storage,anddistribution.
从事生产、质量管理、仓储和销售的职工人数
1.8Useofoutsidescientific,analytical,orothertechnicalassistanceinrelationtomanufactureandanalysis.委外加工和委外检验
1.9Shortdescriptionofthequalitymanagementsystemofthefirmresponsibleformanufacture.质量管理体系描述
2.Personnel人员
2.1Organizationchartshowingthearrangementsforqualityassurance,includingproductionandqualitycontrol.质量保证体系组织机构图，包括生产和质量管理
2.2Qualifications,experience,andresponsibilitiesofkeypersonnel.关键人员简历表
2.3Outlineofarrangementsforbasicandin-servicetrainingandhowrecordsaremaintained.人员培训及其记录
2.4Healthrequirementsforpersonnelengagedinproduction.参与药物生产职工的体检证明
2.5Personnelhygienerequirements,includingclothing.职工卫生要求，包括着装
3.PremisesandequipmentPremises厂房
3.1Simpleplanordescriptionofmanufacturingareaswithindicationofscale(architecturalorengineeringdrawingsnotrequired).生产布局图（并非建筑工程图），标明比例
3.2Natureofconstructionandfinishes.建筑和装饰的性质
3.3Briefdescriptionofventilationsystems.Moredetailsshouldbegivenforcriticalareaswithpotentialrisksofairbornecontamination(schematicdrawingsofthesystemsaredesirable).Classificationoftheroomsusedforthemanufactureofsterileproductsshouldbementioned.空气净化系统描述（系统简图），必须提供可能产生空气污染的临界面积，生产区域的洁净级别划分
3.4Specialareasforthehandlingofhighlytoxic,hazardous,andsensitizingmaterials.处理有毒、有害、易燃、易爆等危险品的特殊区域
3.5Briefdescriptionofwatersystems(schematicdrawingsofthesystemsaredesirable),includingsanitation.水系统描述（系统简图），包括消毒设施
3.6Descriptionofplannedpreventivemaintenanceprogrammesforpremisesandoftherecordingsystem.Equipment设备维修计划及其记录的描述
3.7Briefdescriptionofmajorequipmentusedinproductionandcontrollaboratories(alistofequipmentisnotrequired).生产及检验的关键设备一览表
3.8Descriptionofplannedpreventivemaintenanceprogrammesforequipmentandoftherecordingsystem.维修计划及其记录的描述
3.9Qualificationandcalibration,includingtherecordingsystem.Arrangementsforcomputerizedsystemsvalidation.Sanitation验证，校验，包括记录系统，计算机系统，卫生设施
3.10Availabilityofwrittenspecificationsandproceduresforcleaningmanufacturingareasandequipment.现场及设备清洁的现行有效程序
4.Documentation文件
4.1Arrangementsforthepreparation,revision,anddistributionofnecessarydocumentationformanufacture.文件的编写、修改及发放等的管理制度
4.2Anyotherdocumentationrelatedtoproductqualitythatisnotmentionedelsewhere(e.g.,microbiologicalcontrolsonairandwater).与产品质量相关的其他文件，包括对空气和水的微生物要求等
5.Production生产
5.1Briefdescriptionofproductionoperationsusing,whereverpossible,flowsheetsandchartsspecifyingimportantparameters.生产工艺流程图
5.2Arrangementsforthehandlingofstartingmaterials,packagingmaterials,andbulkandfinishedproducts,includingsampling,quarantine,release,andstorage.对原辅料、包装材料、成品的贮藏、取样、检验、放行等管理制度
5.3Arrangementsforthehandlingofrejectedmaterialsandproducts.不合格原料及产成品处理程序
5.4Briefdescriptionofgeneralpolicyforprocessvalidation.生产关键过程控制描述
6.Qualitycontrol质量控制
6.1Descriptionofthequalitycontrolsystemandoftheactivitiesofthequalitycontroldepartment.Proceduresforthereleaseoffinishedproducts.对质量控制体系及其活动进行描述，产品放行流程。
7.Contractmanufactureandanalysis加工及检验合同
7.1DescriptionofthewayinwhichtheGMPcomplianceofthecontractaccepterisassessed.对加工、检验的受委托方进行符合GMP要求的审核
8.Distribution,complaints,andproductrecall销售、投诉、产品召回
8.1Arrangementsandrecordingsystemfordistribution.销售系统描述及其记录
8.2Arrangementsforthehandlingofcomplaintsandproductrecalls.投诉及产品召回管理制度
9.Self-inspection自检
9.1Shortdescriptionoftheself-inspectionsystem自检体系描述