上海化工研究院检测中心成为首家化学品安全评价GLP

不久前,国家认监委正式批准上海化工研究院检测中心通过良好实验室规范(英文简称GLP)评价,该实验室成为认监委批准的首家化学品安全评价GLP实验室,标志着国家认监委GLP监控体系取得重大进展。中国合格评定国家认可中心为该实验室颁发了全国首张化学品安全评价GLP实验室技术评价合格证书。GLP是英文Good Laboratory Practice的缩写,最早产生于美国药品行业,后扩大到化学品,在国际上已开展了近30年。GLP主要针对医药、农药、食品添加剂、化妆品、兽药等进行的安全性评价实验而制定的规范,主要目的是严格控制化学品安全性评价试验的各个环节,即严格控制可能影响实验结果准确性的各种主客观因素,降低试验误差,确保实验结果的真实性。根据2008年6月1日开始实施的欧盟REACH法规的相关规定,进入欧盟市场的所有化学品必须在规定的时间内凭GLP实验室出具的安全性评价数据到相关部门登记注册,方可在欧洲市场销售。我国化学品对欧贸易量逐年递增,REACH法规的实施对我国的化学品贸易造成了严重影响。目前国内还没有获得有关国际组织认可的GLP实验室,相关的产品安全性评价工作只能依靠国外的GLP实验室,检测费用高昂,企业为此...     

高效液相色谱实验室的良好规范（GLP）

高效液相色谱实验室的良好规范(GLP)@张庆和$大连依利特分析仪器有限公司 @李彤$大连依利特分析仪器有限公司~~     

2011年实验室资质认定评审工作要求

为了进一步提升实验室资质认定（国家计量认证）评审活动的质量和效率,规范行政审批流程,有关2011年实验室资质认定（国家计量认证）评审工作要求如下。     

加强实验室管理工作初探

实验室管理是科研工作的重要保障,对实验室实行科学系统的管理是规范实验秩序、保证实验室正常运行和提高实验效果的必要手段.阐述了实验室管理的基本任务.提出了加强实验室管理的建议.     

有机化学实验室安全与环境保护的思考与实践

针对实验室安全与环境保护2个方面存在的问题,结合教学经验,并查阅了一些国内外的相关文献资料,提出了一些解决问题的办法,如加强师生有机化学实验室安全环保教育和培训、完善实验室安全应急装置的配备、培养学生安全规范的实验操作技能、对实验室废弃物进行无害化处理、营造安全环保文化氛围、借鉴国外高校实验室安全环保工作经验等。     

借鉴美国主流高校EHS体系建设我国的实验室安全文化

以美国化学类专业排名前30的高等院校的环境安全与健康管理体系(Environment,HealthSafety,简写为EHS)为研究对象,进行了信息的收集、分析与整合,从中总结出美国高校EHS管理体系的6个特点;进一步介绍了美国高校EHS管理体系架构的确立与运作。结合目前我国高校实验室安全管理存在的主要问题,提出了建设、发展和丰富我国高校的实验室安全文化是当前最基础性的建设任务之一,以期引起高校管理部门对安全问题的真正重视并落实到行动中。     

实验室熟练水平测试方案简介

介绍了实验室熟练水平测试方案(LPTS)的目的,类型,以及实验室熟练水平测试的组织、基本运行程序和实施的具体步骤。     

现代化实验室规划设计与装备配置的探讨

建设规范、专业的现代化实验室是满足科技快速发展和提高检测能力的需要.现代化实验室规划设计和装备配置是实验室硬件设施建设的重要内容,也是实验室建设成功的基础.本文结合实验室建设管理实践,就现代化实验室规划设计与装备配置进行分析,对现代化实验室的基础建设具有重要的现实指导意义.     

国内首家代谢综合症新药重点实验室成立

不久前,国内首家代谢综合症新药重点实验室落户苏州西交利物浦大学。今后这座实验室将有数百名中外科研人员参与研究工作,成为苏州开展国内外生物医药领域科技合作交流的窗口。据悉,我国目前约10％的成人患有代谢紊乱综合症和糖尿病,另有16％的成人处于糖尿病发病前期,并呈上升趋势。由于发病机理不清楚,世界上尚无根治此类疾病的药物。作为苏州市“十二五”科技应用基础研究项目之一,该重点实验室的建成将针对这一问题进行临床应用研究,为开发诊断试剂提供基础。与此同时,还要进行糖尿病、心血管病生物药的研制,如胰升糖素样肽类似物（GLP）,治疗糖尿病的中药试剂、抗氧化剂、微小核酸和反义核酸等。     

第四届全国实验室管理科学研讨会征文通知

由中国分析测试协会主办、《分析试验室》编辑部承办的“第四届全国实验室管理科学研讨会”定于2009年7月在甘肃省兰州市召开。会议内容包括实验室管理科学、实验室认证认可、实验室比对、实验室信息管理系统（LIMS）、实验室仪器设备运行及考核、实验室技术人员培训等有关方面的学术研讨。会议将邀请有关专家做大会报告,欢迎全国各行业的实验室管理人员及实验室科研工作人员参加会议。     

Getting the most from your laboratory information system in the hematology laboratory

As laboratories continue to downsize, commercialize and become more businesslike in today’s managed care environment, their present and future success will greatly depend on the efficiency and flexibility of their laboratory information system (LIS). Today, LIS is a primary tool for managing business and communication. Laboratories that hope to remain competitive in today’s dynamic health care must continue to implement new and innovative approaches with their LISs. Received: 26 July 2002 Accepted: 6 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium     

Education and training of laboratory staff as a part of laboratory competence

Competence of laboratory staff is an important part of the technical competence of each laboratory. Because the speed at which knowledge goes out of date is increasing, maintaining laboratory staff competence at an appropriate level can be a very demanding requirement, especially for laboratories operating in a free market with little or no financial help from the state or from the larger organisation they possibly belong to. In order to manage staff competence effectively and efficiently, a laboratory must first define its services and the processes needed for realisation of these services. Responsibility for each step in these processes can then be assigned and gap analysis of current competence can be performed. This article analyses the requirements of ISO/IEC 17025 standard and gives some practical advice and solutions how to organize and manage staff competence.     

Traceability in laboratory medicine

In laboratory medicine meaningful measurements are essential for diagnosis, risk assessment, treatment and monitoring of patients. Thus methods applied in diagnostic measurements must be accurate, precise, specific and comparable among laboratories. Inadequate or incorrect analytical performance has consequences for the patients, the clinicians, and the health care system. One key element of metrology is the traceability of a measurement result to the SI system ensuring comparable results. This principle is described in the ISO/TC 212/WG2 N65 prEN 17511 Standard. In addition to the principles of metrology, the clinical usefulness, the diagnostic needs, and the biological and disease associated variations in patients' specimens have to be considered when the analytical biases for diagnostic purposes are defined. It must be the general goal of diagnostic laboratories to produce results that are true and comparable worldwide. The recent European in vitro diagnostic (IVD) Directive 98/79 EC follows the above mentioned standard of the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) requesting its application for all IVD reagents used within the European Union. This new European legislation will have a worldwide impact on manufacturers and clinical laboratories and will be implemented in 2003. It states that "traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of a higher order". Thus a worldwide reference system needs to be established by collaboration and mutual recognition between the United States National Institute of Standards and Technology (NIST), European Metrology Institutes (EUROMET), regulatory bodies (e.g. United States Food and Drug Administration, FDA) the IVD industry and professional organizations (e.g. International Federation of Clinical Chemistry and Laboratory Medicine, IFCC). In June 2002, in Paris, representatives of international and regional organizations and institutions decided to form the "Joint Committee on Traceability for Laboratory Medicine" (JCTLM), which will support industry in registration and licensing of the "CE" label to test systems conforming to the IVD Directive.Presented at the International ILAC/IAF Conference on Accreditation in Global Trade, 23–25 September 2002, Berlin, Germany     

Microcomputers in the laboratory

Zusammenfassung Im vorliegenden zweiten Teil der dreiteiligen Übersicht über den Einsatz von Mikrorechnern im Laboratorium werden die Hilfsmittel vorgestellt, die für die Herstellung funktionsfähiger Programme zur Verfügung stehen.

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Microcomputers in the laboratoryII. Software

Summary In the present second part of the three-part review on microcomputers in the laboratory available aids are discussed for preparing efficient programs.

I. Mitt.: Fresenius Z. Anal. Chem. 296, 18 (1979)     

Small laboratory computer networks

The rational approach to laboratory automation in a changing research environment involves a network of computers. This permits program preparation and data manipulation/storage/plotting/printing to take place on the CPU most appropriate to the task. It also allows the application programs to run on satellite processors with minimum configuration and maximum data throughput capabilities. The hardware implementation is described, as well as a brief introduction to the software facilities available under RT-11/REMOTE and FORTH, the two language systems used at Virginia Polytechnic Institute to implement the net.