2011-PIC-S-工厂主文件指南

2011PIC/S工厂主文件指南PHARMACEUTICALINSPECTIONCONVENTIONPHARMACEUTICALINSPECTIONCO-OPERATIONSCHEME药品检查协定和药品检查合作计划组织PE00841Annex1January2011PE0084附件一2011年1月1日EXPLANATORYNOTESFORPHARMACEUTICALMANUFACTURERSONTHEPREPARATIONOFASITEMASTERFILE制药工厂现场主文件编写说明?PIC/SJanuary2011ReproductionprohibitedforcommercialpurposesReproductionforinternaluseisauthorizedProvidedthatthesourceisacknowledgedEditor/编著:PIC/SSecretariatemail/邮箱:[e-mail]/网站:工厂主文件指南1DocumentHistory/文件历史...................................................................................22Introduction/简介....................................................................................................23Purpose/目的.........................................................................................................24Scope/范围............................................................................................................35ContentofSiteMasterFile/现场主文件内容..........................................................36RevisionHistory/修订历史.....................................................................................31DOCUMENTHISTORY文件历史2INTRODUCTION简介AdoptionbythePICCommitteeofOfficialsofPH4/93PIC委员会正式采用PH4/9322-23April19931993年4月22-23EntryintoforceofPH4/93PH4/93生效April19931993年3月EntryintoforceofPE0081PE0081生效1November20022002年11月1日2.1TheSiteMasterFileispreparedbythepharmaceuticalmanufacturerandshouldcontainspecificinformationaboutthequalitymanagementpoliciesandactivitiesofthesite,theproductionand/orqualitycontrolofpharmaceuticalmanufacturingoperationscarriedoutatthenamedsiteandanycloselyintegratedoperationsatadjacentandnearbybuildings.Ifonlypartofapharmaceuticaloperationiscarriedoutonthesite,aSiteMasterFileneedonlydescribethoseoperations,e.g.analysis,packaging,etc.现场主文件是由制药厂家编写，并包含以下信息：质量管理方针及现场活动、在对在指定现场进行生产或/和对在指定现场的制药生产操作进行的质量控制以及在临近及附近建筑内进行的一体化操作。如果仅有一部份制药操作在该现场进行，那么SMF仅需描叙该类操作即可，如：分析、包装、等。2.2Whensubmittedtoaregulatoryauthority,theSiteMasterFileshouldprovideclearinformationonthemanufacturer’sGMPrelatedactivitiesthatcanbeusefulingeneralsupervisionandintheefficientplanningandundertakingofGMPinspections.提交至监管机构时，SMF需提供明确信息，说明厂家进行的有助于一般监管和GMP审查有效计划和应对的相关GMP活动2.3ASiteMasterFileshouldcontainadequateinformationbut,asfaraspossible,notexceed25-30pagesplusappendices.Simpleplans,outlinedrawingsorschematiclayoutsarepreferredinsteadofnarratives.TheSiteMasterFile,includingappendices,shouldbereadablewhenprintedonA4papersheets.2011PIC/S工厂主文件指南SMF应包含足够的信息，但是加上附件不得超过25-30页。相较于详述，简单性计划、简略的原理图布局图为首选。SMF，包括附件，用A4纸打印出来应当可读。2.4TheSiteMasterFileshouldbeapartofdocumentationbelongingtothequalitymanagementsystemofthemanufacturerandkeptupdatedaccordingly.TheSiteMasterFileshouldhaveaneditionnumber,thedateitbecomeseffectiveandthedatebywhichithastobereviewed.Itshouldbesubjecttoregularreviewtoensurethatitisuptodateandrepresentativeofcurrentactivities.EachAppendixcanhaveanindividualeffectivedate,allowingforindependentupdating.SMF厂家质量管理系统文件的一部分，应进行相应更新。SMF应当有一个版本号、生效日期以及需进行审核的日期。应对SMF进行定期审核以保证其为最新版本并体现最新行动。每个附件可有单独的生效日期，允许单独对附件进行更新。3PURPOSE目的TheaimoftheseExplanatoryNotesistoguidethemanufacturerofmedicinalproductsinthepreparationofaSiteMasterFilethatisusefultotheregulatoryauthorityinplanningandconductingGMPinspections.本说明的目的是指导医药生产厂家进行SMF的编写。SMF在监管机构进行GMP审查计划和执行GMP审查中是有用的。4SCOPE适用范围TheseExplanatoryNotesapplytothepreparationandcontentoftheSiteMasterFile.Manufacturersshouldrefertoregional/nationalregulatoryrequirementstoestablishwhetheritismandatoryformanufacturersofmedicinalproductstoprepareaSiteMasterFile.本说明使用与SMF的编写及内容。厂家应参考地区／国家法规要求以确定是否强制要求医药用品厂家编写SMF。TheseExplanatoryNotesapplyforallkindofmanufacturingoperationssuchasproduction,packagingandlabelling,testing,relabellingandrepackagingofalltypesofmedicinalproducts.TheoutlinesofthisguidecouldalsobeusedinthepreparationofaSiteMasterFileorcorrespondingdocumentbyBloodandTissueEstablishmentsandmanufacturersofActivePharmaceuticalIngredients.本说明适用于下述此类生产操作：所有类型医药产品的生产、包装和贴标、检验、再贴标和再包装。本指南的大纲也可以用于编写SMF或API血液和组织制造机构以及生产厂家相关文件的编写。5CONTENTOFSITEMASTERFILEＳＭＦ内容RefertoAnnexfortheformattobeused.SMF格式见附件。2011PIC/S工厂主文件指南6REVISIONHISTORY修订历史Date日期VersionNumber版本号1November20022002年11月1日PE0081Revisionofformat(inlinewithSOPonSOPs)andintroduction;deletereferencetotheSiteMasterFileasbeingPartBofthePIC/Sinspectionreport;newpointC.5.3onreprocessing/rework;betterdistinctionbetweenQualityAssuranceandQualityControl;explanationofabbreviations;minoreditorialchanges.AllchangesadoptedatPIC/SCommitteemeetingon8October2002.格式（与SOP一致）及简介修订；取消将SMF作为PIC/S审查报告的Ｂ部；C.5.3再加工／返工的新要点；质量保证和质量控制的进一步区分；缩略词的解释；小幅编辑修改。所有变更均在PIC/S委员2002年10月8日召开的会议上被采用。1July20042004年６月1日PE0082ChangeintheEditor’scoordinates编者协调变更25September20072007年９月２５日PE0083ChangeintheEditor’scoordinates编者协调变更1January20112011年１月１日PE0084Simplificationofthedocumentandimplementationofrequirementsrelatedtoqualityriskassessmentpolicy简化文件以及质量风险评估政策相关要求的执行AnnextoPE0084CONTENTOFSITEMASTERFILE现场主文件内容1GENERALINFORMATIONONTHEMANUFACTURER工厂一般信息2011PIC/S工厂主文件指南