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研究科研机构简介的中英文翻译
发布时间:2011/8/16  阅读次数:7137  字体大小: 【】 【】【
研究科研机构简介的中英文翻译
Brief Introduction to XXX Institute of Pharmaceutical Industry
  
XXX药品检验所成立于1953年8月1日,是XXX食品药品监督管理局下属的独立法人单位,是对XXX药品、医疗器械、药包材的研究、生产、流通、使用全过程实施技术监督的法定机构,是国家对药品质量监督保证体系的重要组成部分。其主要职责是:(1)承担XXX境内的药品监督检验、注册检验、强制检验、复核检验和委托检验;(2)承担XXX境内医疗器械的检测;(3)承担XXX境内药品包装材料(容器)的检测;(4)完成XXX食品药品监督管理局委托的全省药品、医疗器械抽验计划的起草及抽验计划实施的组织工作,承担国家和本辖区内抽查检验计划中的抽验任务和抽样工作,提供XXX药品、医疗器械质量公报所需的技术数据和质量分析报告,开展司法鉴定工作,为行政和司法部门提供技术支撑;(5)承担国家药品标准和省医疗器械标准的起草,修订任务和药品、医疗器械、药包材等注册检验,试行标准转正的有关技术复核检验;   (6)开展药品、医疗器械检验方法、质量标准、药品质量以及与质量有关的安全性、有效性等相关的科研工作;(7)承担对省内各级药检所和XXX境内药品、医疗器械、药包材生产、经营、使用单位质量检验机构的业务技术指导、培训;(8)负责全省药物不良反应、药物滥用情况的监测;(9)承担全省医疗器械不良事件监测工作;(10)负责药品检验用标准品、对照品的联系供应,承担中国药品生物制品检定所委托的部分国家标准物质的协作标定工作。(11)开展保健食品的注册检验工作。
Established on August 1, 1953, XXX Institute of Pharmaceutical Industry is an independent legal impersonal entity subject to XXX Provincial Food & Drug Administration that engaging in technical supervision on research, production, circulation and use of medicine, medical appliance & packaging. As a major component of the State medicine quality supervision and warranty system, the responsibilities of the Institute are: (1) undertake medicine supervision inspection, registration inspection, forced inspection, checking inspection and entrusted inspection for XXX Province; (2) undertake medical appliance inspection for XXX Province; (3) undertake the inspection on medical packaging (vessel) for XXX Province; (4) draft selective test plan for medicine and medical appliance entrusted by XXX Provincial Food & Drug Administration; undertake selective test and sampling work specified in selective test plan of the State or the administrative area; provide technical data and quality analysis report demanded by XXX Quality Bulletin on Medicine and Medical Appliance; perform judicial judgment so as to back up administrative and judicial departments technically; (5) draft State medicine standards and provincial medical appliance standards; modify tasks and registration inspection on medicine, medical appliance & packaging; perform technical checking inspection on turning tentative standard to official standard; (6) research on inspection method, quality standard for medicine and medial appliance, medicine quality and safety and effectiveness concerning quality; (7) provide technical guidance and training for institutes of pharmaceutical industry of all levels and quality inspection organs for production, sales and use units of medicine, medical appliance & packaging; (8) monitor untoward medicine effect and drug abuse of the province; (9) monitor medicinal appliance accident of the province; (10) supply standard sample and check sample for medicine control; perform staking-out work for some State standard substances entrusted by National Institute of the Control of Pharmaceutical and Biological Products (11) perform registration examination for health care foods.
半个世纪以来,XXX药品检验所先后在省卫生厅和省食品药品监督管理局的直接领导下,在中国药品生物制品检定所的业务指导下,通过全所职工的共同努力,由小到大,现已发展成为技术力量雄厚、专业学科齐全、实验设施完备、业务管理规范,能承担辖区内药品、食品、医疗器械、药品包装材料(容器)产品质量技术监督和检验任务的唯一法定省级检验机构。
For over half a century, XXX Institute of Pharmaceutical Industry, under the direct leadership of XXX Provincial Department of Health and XXX Provincial Food & Drug Administration and with the guidance from National Institute of the Control of Pharmaceutical and Biological Products, has developed gradually into one provincial inspection organ that can undertake technical supervision and examination task on medicine, foods, medical appliance, medical packaging (vessel) with powerful technology, complete subjects and laboratory equipment and regulated business management through joint effects of all the employees.   
目前,现有领导班子一正六副共七人。全所在职职工有176人,离退休职工58人。各类专业技术人员144人,其中具有高级技术职称的51人,具有中级技术职称52人,大学本科以上人数约占总人数的60%。在专业技术队伍中,拥有享受国务院政府特殊津贴专家、国家药典委员会委员,国家药品审评专家、中药品种保护审评委员,国家GMP认证员,省新药评审专家、硕士导师等20余人构成的专家群体。
Presently, the Institute comprises one chief leader and six deputy leaders, 176 employees, 58 retired employees, 144 technicians, of which 51 are awarded with senior technical professional title, 52 are with medium technical professional title. The employees with undergraduate diploma account for 60% of the total. The professional technical team of the Institute is composed of about 20 experts enjoying special government allowance, members of China Pharmacopoeia Committee, experts in medicine evaluation, experts in traditional Chinese medicine protection and evaluation, State GMP certification clerks, provincial experts in new medicine evaluation and master tutor.
XXX食品药品检验所内设五个检验科室:化学室、中药室、抗生素室、生化药理室、食品室;三个业务职能科室:业务科、药品监督抽验办公室、质量保证科;四个行政职能科室:所(党委)办公室、人事科、财务科室、行政总务科,另省医疗器械与药包材检测所、省药物不良反应与药物滥用监测中心隶属所内。为了拓展业务,搞好医药科技服务,成立了XXX药品研究服务中心。
The Institute is composed of five clinical laboratories such as chemical laboratory, traditional Chinese medicine laboratory, antibiotics laboratory, biochemical pharmacological laboratory and foods laboratory, three functional divisions such as business division, medicine supervision and selective test office and quality warranty division, four administrative divisions such as institute (the Party committee) office, personnel division, financial office and administrative office management. Additionally, the provincial medical appliance and drug packing material control institute and the provincial untoward medicine effect and drug abuse monitor center are subject to the Institute. To further develop the business and do a good job in medical scientific service, XXX Provincial Medicine Research and Service Center is established.
目前XXX药品检验所建筑面积共17800平方米,实验用房及配套用房15000平方米,拥有液-质联用、高效液相色谱仪、气相色谱仪、原子吸收分光光度计、薄层扫描仪、全自动溶出仪、红外分光光度计、紫外分光光度计等大型精密仪器179台(件),净资产总值达6000万元。
At present, the floor area of the Institute is 17,800 m2, including 15,000 m2 for laboratories and supporting rooms. The Institute has 179 large precise instruments such as LC-MS high performance liquid chromatograph, gas chromatograph, atomic absorption spectrophotometer, thin layer scanner, automatic stripping apparatus, infrared spectrophotometer, ultraviolet spectrophotometer etc. valuing RMB 60 million Yuan.
2000年至2006年完成了检品(包括药品、保健食品)49266批,其中注册品种12700批,医疗器械、药包材1088批,上报药品不良反应报表59151份,药物滥用调查表数12089份,医疗器械不良事件报表数1492份;完成了《中国药典》2005年版正文中29个品种质量标准的起草和67个品种的复核、附录中酸败度检查法的修订、甲醇量检查和鞣质测定方法的实验复核、《药品红外光谱集》中19个品种的起草和复核工作。近年获得科技成果奖12项,撰写科技专著18册,发表论文500多篇。
From 2000 to 2006, 49,266 batches of products (including medicine and healthy foods) were tested, including 12,700 batches of registered ones, 1,088 batches of medial appliance and medical packaging, 59,151 untoward medicine effect reports, 12,089 drug abuse reports and 1,492 medical appliance accident reports are submitted, the drafting of 29 varieties and checking of 67 varieties, laboratorial checking for the amendment to rancidity degree checking method in the annex, methanol content checking and tannin testing method in 2005 edition of Chinese Pharmacopoeia and drafting and checking of 19 varieties in Arias of Infrared Spectra of Drugs were completed. In recent years, the Institute has got 12 scientific achievement awards and published 18 monographs and over 500 papers.
为了对社会提供公正性检测数据,进一步确立药检所的权威地位,提高综合技术实力,不断扩大业务范围,XXX药检所非常重视质量体系建设,   于1996年8月通过卫生部组织的省级药品检验所实验室认证;1998、2005年取得XXX技术监督局计量认证合格证;2004年3月实验动物室通过XXX科技厅颁发的实验动物使用许可证;医疗器械、药包材所于2003年8月取得XXX技术监督局的认证合格证之后,分别于2004年11月与2006年12月通过XXX质量技术监督局的计量认证(扩项),于2005年1月与2007年1月通过国家药监局医疗器械司的资格认可(扩项)。
To provide judicial testing data to the society, further develop the authority of the Institute, improve the comprehensive technical forces and continue expand the business scope, the Institute attaches great importance to quality system development and has passed laboratory authentication on provincial institute of pharmaceutical industry organized by the Ministry of Public Health in August 1996 and authentication certificate on measurement by XXX Provincial Bureau of Quality and Technical Supervision in 1998 and 2005. In March 2004, the animal laboratory got animal use certificate issued by the Science & Technology department of XXX Province. After getting the authentication certificate issued by XXX Provincial Bureau of Quality and Technical Supervision in August 2003, the medical appliance & packaging institute passed the measurement authentication (expanded projects) by XXX Provincial Bureau of Quality and Technical Supervision in November 2004 and December 2006 respectively and qualification approval (expanded projects) of Medical Appliance Division of the State Food and Drug Administration in January 2005 and January 2007 respectively.
50多年来,XXX药品检验所经过了创业、探索、发展的奋斗历程,尤其是近年来,XXX药检所迎来了飞速发展的时期。领导班子坚持“以人为本”的管理思想,精诚团结、协调、务实,秉承一切为了人民用药安全有效的宗旨,从自身做起,勤于思考,勇于实践,开拓创新,克服重重困难,努力营造药检工作的内外环境,按照现代化实验室的要求和标准,建成了建筑面积为11000平方米的新实验大楼,每年配置各种新的仪器设备,使检验工作环境和条件大为改善,所容所貌也焕然一新。新的实验室为检验人员提供了一个舒心的工作环境;自动化分析仪器设备保证了检验结果的科学准确。严格的实验室管理,奠定了各项工作有序运行的基础;所内局域网建设,初步实现了办公自动化,提高了工作效率;“科学、公正、优质、高效”的质量方针,明确了药检所的努力方向。
Over the past 50 years, the Institute has experienced carving out, exploration and development. Especially in recent years, the Institute has witnessed fast development. Leaders of the Institute persist in the principle of “people oriented”, unify sincerely and are cooperative and practical to inherit the objective of ensure the safe medicine use. Also, they are meditative, practical and innovative to overcome difficulties to develop sound internal and external circumstances for medicine control. A new laboratory building with a floor area of 11,000 m2 is built and equipped with new equipment year by year to improve the working environment and conditions and the appearance of the Institute. The new laboratory can provide the workers a comfortable working environment and the automatic analytical instrument can ensure the scientificity and accuracy of test result. Moreover, with strict laboratorial management, it has laid a foundation for regular working order. With the development of local area network, it has initially realized office automation and improved the work efficiency. Finally, with the quality principle of “scientific, judicial, excellent and effective”, it has clarified the development objective of the Institute.             
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