仪器设备流程

标准操作规程StandardOperatingProcedureSOP标题SOPTitle仪器/设备管理流程Instrument/EquipmentManagementProcedureSOP编号SOPNo.版本RevNo.01执行日期EffectiveDate复审日期ReviewDatePage1of1SOP审核和批准SOPReviewandApproval职责Responsibility签名Signature日期Date打印名PrintedName职位Title起草人Createdby分析主任AnalyticalDirector复核Reviewedby分析副主任AnalyticalAssociateDirector批准人Approvedby副总经理VicePresident批准人ApprovedbyQA经理QAManagerSOP标题SOPTitle仪器/设备管理流程Instrument/EquipmentManagementProcedurePage2of101.0目的Purpose该规程用于系统性地管理分析实验室内的分析仪器，确保仪器性能满足规定要求。Thisdocumentisusedtosystematicallymanageanalyticalinstrument/equipmentwithinARDlaboratorytoensureequipmentperformancemeetthespecifiedrequirement.2.0范围Scope本程序适用于XXX有限公司分析实验室所有分析仪器。.3.0职责Responsibility3.1操作人Operator负责按照SOP和操作手册正确操作仪器。Beresponsibleforoperatingtheinstrument/equipmentcorrectlyinaccordancewithSOPandoperationmanualforeachinstrument/equipment.负责根据良好文件规范GDP要求，填写仪器记录。Beresponsibleformaintainingrecordinaccordancewithgooddocumentationpractices.3.2仪器管理员InstrumentEquipmentAdministrator负责该规程的起草、修订。BeresponsiblefordraftingandrevisingthisSOP.负责按照文件要求对仪器进行管理。Beresponsibleforinstrument/equipmentmanagementinaccordancewiththisSOP.3.3质量管理专员QA负责文件执行符合性检查。Beresponsibleforcomplianceinspection.4.0简写和定义Abbreviations&Definitions序号S.No.简写ABBREVIATIONS定义DEFINITIONS4.1AIQ分析仪器确认AnalyticalInstrumentQualification4.2DQ设计确认（DQ）是以文本记录的活动汇总，基于仪器预定用途，规定了仪器的功能与操作标准和提供商的选取标准。SOP标题SOPTitle仪器/设备管理流程Instrument/EquipmentManagementProcedurePage3of10序号S.No.简写ABBREVIATIONS定义DEFINITIONSDesignqualification(DQ)isthedocumentedcollectionofactivitiesthatdefinethefunctionalandoperationalspecificationsoftheinstrumentandcriteriafortheselectionofthevendor,basedontheintendedpurposeoftheinstrument.4.3IQ安装确认（IQ）是以文本记录的必要的活动汇总，确认仪器按照设计和规定进行交付，并正确安装在所选的适合的环境中。Installationqualification(IQ)isthedocumentedcollectionofactivitiesnecessarytoestablishthataninstrumentisdeliveredasdesignedandspecified,andisproperlyinstalledintheselectedenvironment,andthatthisenvironmentissuitablefortheinstrument.4.4OQ运行确认是以文本记录的必要的活动汇总，证明仪器设备能够根据操作标准在所选环境中正常运行。Operationalqualification(OQ)isthedocumentedcollectionofactivitiesnecessarytodemonstratethataninstrumentwillfunctionaccordingtoitsoperationalspecificationintheselectedenvironment.4.5PQ性能确认，是以文本记录的必要的活动汇总，证明仪器设备始终能够根据用户规定的标准运行，适合预期用途。Performancequalification(PQ)isthedocumentedcollectionofactivitiesnecessarytodemonstratethataninstrumentconsistentlyperformsaccordingtothespecificationsdefinedbytheuser,andisappropriatefortheintendeduse.4.6URS用户需求说明UserRequirementSpecificationSOP标题SOPTitle仪器/设备管理流程Instrument/EquipmentManagementProcedurePage4of105.0程序PROCEDURE注意：未经校准、确认和超过有效期的仪器不得用于GMP实验。Note:Non-calibrated,unqualifiedandexpiredequipmentshouldnotbeusedforGMPpurpose.5.1仪器/设备分类Instrument/EquipmentCategories分析部门的仪器按仪器的使用需要，分为3类。Onthebasisofthelevelneeded,theinstrument/equipmentiscategorizedintothreegroups:A,B,andC,asdefinedbelow.5.1.1A类GroupAA类包括没有测量能力或常规校准要求的标准仪器设备。A类设备与用户需求的符合性可以通过肉眼观察其操作来确认。此类设备的例子有磁力搅拌器和离心机。GroupAincludesstandardinstrument/equipmentwithnomeasurementcapabilityorusualrequirementforcalibration.ConformanceofGroupAequipmentwithuserrequirementsmaybeverifiedthroughvisualobservationofitsoperation.Examplesofequipmentinthisgrouparemagneticstirrersandcentrifuge.5.1.2B类GroupBB类包括能够提供测量数据和设备控制的需要校准物理参数（例如温度、压力或流量）的标准仪器/设备，其中用户需求通常与制造商的功能标准和操作限度相同。B类仪器或设备对用户需求的符合性是按照该仪器或设备的确认和校验来确定的。此类设备的例子有天平、pH计和烘箱。GroupBincludesstandardinstrument/equipmentprovidingmeasuredvaluesaswellasequipmentcontrollingphysicalparameters(suchastemperature,pressure,orflow)thatneedcalibration,wheretheuserrequirementsaretypicallythesameasthemanufacturer’sspecificationoffunctionalityandoperationallimits.ConformanceofGroupBinstrumentsorequipmenttouserrequirementsisdeterminedaccordingtothequalificationandcalibrationfortheinstrumentorequipment.Examplesofequipmentinthisgrouparebalance,pHmeterandovens.5.1.3C类GroupCC类包括在分析应用上，对功能、操作、性能范围上有特定的用户需求的仪器。C类仪器对用户需求的符合性通过具体的功能测试和性能测试来测定。此类设备的例子有液相、气相和溶出仪。GroupCincludesinstrumentswhereuserrequirementsforfunctionality,operational,andperformancelimitsarespecificfortheanalyticalSOP标题SOPTitle仪器/设备管理流程Instrument/EquipmentManagementProcedurePage5of10application.ConformanceofGroupCinstrumentstouserrequirementsisdeterminedbyspecificfunctiontestsandperformancetests.ExamplesofequipmentinthisgroupareHPLC,GCanddissolutionapparatus.5.2仪器/设备编号Instrument/EquipmentIDNo.仪器管理员应给予每台/设备唯一的编号，仪器报废后，此编号不得再使用。编号方法如下所示：Equipmentadministratorshouldassigneachinstrument/equipmentauniqueIDNo.Afterinstrument/equipmentisscraped,thecodeshouldnotbereused.Thenumberingmethodisindicatedasbelow,ARD-XX-YYY此处WhereARD=分析研发AnalyticalresearchdevelopmentXX=仪器/设备缩写，大写字母，不少于2个。现有仪器/设备缩写举例，参见附件-A。Instrument/EquipmentAbbreviation,writtenincapitalsandnotlessthan2letters.Fortheabbreviationexampleofcurrentexistinginstrument/equipment,refertoAppendix-A.YYY=仪器/设备编号，从001开始。NumberingoftheInstrument/Equipmentstartingfrom001,002…5.3仪器/设备标识Instrument/EquipmentLabelling每台仪器应有2个标识，仪器信息标识和校验状态标识。标签举例参见附件-B。Eachinstrument/equipmentshouldhave2labels:instrument/equipmentidentificationlabelandcalibration