深圳市药品检验研究院简介

2016-09-21

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深圳市药品检验研究院成立于1982年(2003年加挂“深圳市医疗器械检测中心”牌子),是依法执行国家对药品、保健食品、化妆品、医疗器械技术监督检验的法定性专业检验机构和科研机构。是国家授权的化妆品行政许可检验机构、港澳地区中成药注册检验机构、医疗器械监督检验注册检验机构、保健食品注册检验复核检验机构、广东省保健食品化妆品监督检验机构、广东省国产非特殊用途化妆品备案检验机构,是国家博士后科研工作站设站单位、广东省和深圳市博士后创新实践基地。

Shenzhen Institute for Drug Control (SZIDC) was established in 1982, and added with Shenzhen Testing Center of Medical Devices (STCMD) since 2003. It is a legally authorized testing and research institute which implements quality supervision and inspection on drugs, health food, cosmetics, and medical devices. It is also the State-authorized administrative testing agency for cosmetic licensing approval, the registration inspection agency for Chinese Traditional Patent Medicines in Hong Kong and Macao, the supervision and registration inspection agency for medical devices, the registration and review inspection agency for health food. In Guangdong Province, SZIDC is one of the supervision and inspection agencies for health food and cosmetics, and one of the record registration inspection agencies for domestic non-special-purpose cosmetics. Furthermore, SZIDC is the national post-doctoral workstation and the post-doctoral innovation practice bases for Guangdong Province and Shenzhen City.

深圳市药品检验研究院内部设有化学药品检验室、中药检验室、保健食品化妆品检验室、药理毒理室、微生物检验室、分析测试研究室、无源医疗器械检测中心、体外诊断试剂检测部、有源医疗器械检测部9大检验部门和业务技术科、质量管理科、信息化管理办公室等职能部门。

There are 9 testing departments including Chemical Drugs Testing Department, Traditional Chinese Medicine Testing Department, Health food and Cosmetics Testing Department, Pharmacology and Toxicology Department, Microbiological Testing Department, Analysis and Testing Research Department, Non-active Medical Devices Testing Department, In-vitro Diagnostic Reagents Testing Department and Active Medical Devices Testing Department, as well as seven administrative departments including Business and Technology Department, Quality Management Department, Information Technology Department, etc.

深圳市药品检验研究院拥有工作人员200余名,其中硕士53人,博士、博士后15人。中级以上技术职称82人,其中高级职称41人(主任药师/主任中药师17人,副主任药师/副主任中药师/高级工程师24人)。形成了包括国务院政府特殊津贴专家、深圳市政府特殊津贴专家、国家药典委员、国家保健食品审评专家、国家实验室认可评审员、资质认定评审员、深圳市高层次专业技术领军人才、博士生导师、硕士生导师等专家群体。

There are nearly 200 personnel in SZIDC, about 53 of them have master degree and 15 of them have doctor degree. And 41 of them with senior professional title (17 chief pharmacists and 24 associate chief pharmacists). The professional group includes experts enjoying the State Council Special Allowance and the Special Allowance of Shenzhen Municipal Government, Members of Chinese Pharmacopeia Commission, National Health food Evaluation Expert, CNAS and CMA Auditors, Shenzhen High-level Leading Technical Talents, Doctoral and Master’s Supervisors.

深圳市药品检验研究院拥有核磁共振波谱仪、X-射线粉末衍射仪、液质联用仪、超高效液相色谱仪等各类精密仪器2000余台/套,2015年底固定资产总值3.5亿元。建立了实验室信息化管理(LIMS)、科学数据管理(SDMS)、数据分析(SDC)、综合办公管理(OA)、资产管理(AMS)为一体的“智慧药检”系统平台。

Currently, SZIDC has more than 2,000 sets of advanced testing equipments including nuclear magnetic resonance spectrometer, X-ray diffract meter, liquid chromatography-mass spectrometry (LC-MS) and ultra high performance liquid chromatography, etc. By the end of 2015, the total value of the assets has exceeded RMB 350 million. SZIDC has developed “Intelligence SZIDC” computer management systems which including Laboratory Information Management System (LIMS), Scientific Data Management System (SDMS), Data Analysis System (DAS), Office Automation (OA) and Asset Management System (AMS).

深圳市药品检验研究院是全国药检系统首批获准中国合格评定国家认可委员会(CNAS)认可的实验室。检验范围涵盖药品、保健食品、化妆品、医疗器械、药包材、洁净区(室)环境、实验用水等8大类800余项检验项目,4000余项参数,检验结果得到多个国家、地区和国际组织的互认。

SZIDC was one of the first Drug Control Laboratories which were accreditated by China National Accreditation Service for Conformity Assessment (CNAS). Its testing scope has covered over 800 items with a total of 4,000-plus parameters in eight categories – drugs, foods, cosmetics, medical devices, drug packaging materials, clean area, and water for analytical laboratory use. The testing results are well accepted by a large number of countries, regions and international organizations.

深圳市药品检验研究院作为药品检验的专业技术机构,承担基本药物、重点药物品种的质量筛查及仿制药质量和疗效一致性评价工作,负责国家、省、市政府监督性、评价性检验和各项专项检验任务。承担药品、保健食品、化妆品、医疗器械质量标准制修订工作。与世界卫生组织(WHO)广泛开展交流与合作,承接《国际药典》及全球基金项目标准起草。

As a professional technical institute in drug control, SZIDC carries out screening inspections on basic drugs and key medicines, undertakes the consistency evaluation for generic drugs, implements the supervision and evaluation and other special inspection tasks of national, provincial and local governments. SZIDC undertakes the drafting and revision work of quality standards in drugs, health food, cosmetics and medical devices. The institute also has cooperated with WHO and carried out monographs drafting of “International Pharmacopoeia” and “Global Fund Project”.

深圳市药品检验研究院建立了“深圳生物医药安全检测和评价公共技术服务平台”、“深圳医疗器械产品检测公共服务平台”两个平台和“深圳药品质量标准研究重点实验室”、“深圳岭南道地药材资源开发与应用工程实验室” 两个市级重点实验室。与沈阳药科大学、暨南大学、香港科技大学、澳门大学、清华大学深圳研究生院等高校签署合作协议。建立了岭南中药材蜡叶标本电子库;成功开发了“褪黑素”等药品检验快速筛查试剂盒/试纸;建立了药品中非法添加化学物质快速筛查数字化检验平台,可筛查9大类700余种化学物质。近年来,在国内外知名期刊发表论文400余篇,申请国内外发明专利25项, PCT专利4项,获授权发明专利11项,其中PCT专利“中成药和保健食品中掺杂褪黑素的快速测定方法”获得美国专利商标局授权并入选深圳市2015年度知识产权十大事件。科研项目荣获广东省科学技术奖、深圳市科技创新奖、深港科技创新大奖、科研创新卓越奖、深圳市标准化战略等多项奖励。

SZIDC has built two key labs within Shenzhen, one is Key Laboratory of Pharmaceutical Standard Research, another is Key Laboratory for Lingnan Famous-region Chinese Materia Medica Resources Development and Application, and two public platforms in local city, namely the Biomedical Safety Assessment and Evaluation Platform and the Public Platform of Medical Devices Testing. Moreover, we have signed cooperative agreements with six colleges and universities including the University of Science and Technology of Hong Kong, University of Macau and Shenzhen Graduate School of Tsinghua University,. We have build exsiccate electronic library of Lingnan herbs. As for the phenomena of illegal additives in medicine, health food and cosmetics, the Institute has successfully developed several quick screening kits/test papers. It has set up a inspection platform which can quickly screen over 700 kinds of chemical substances of 9 major categories. In recent years, over 400 articles of SZIDC have been published in famous domestic and international professional journals, 25 innovation patents and 4 PCT patents were applied, and 11 patent licenses have been obtained. . The PCT patent of “the method for quickly determining the melatonin mixed in proprietary Chinese medicines and health food” has been authorized by the United States Patent and Trademark Office and was selected as one of the top ten intellectual property events in Shenzhen in 2015. Our research projects have obtained many rewards such as Guangdong Province Science and Technology Award, Shenzhen Scientific Innovation Award, Shenzhen Hong Kong Scientific Innovation Big Award, Outstanding Scientific Innovation Award, and Shenzhen Standardization Strategy Award,etc.

总投资7亿余元,建筑面积4.6万平方米的“深圳市医疗器械检测和生物医药安全评价中心”综合实验大楼于2016年9月破土动工,预计将于2020年落成使用,实验设施、仪器设备将达到国际一流,国内领先水平。

The new building with 46,000 m2 area named “Shenzhen testing centre of medical devices and Biomedical safety evaluation center” began to be built since September, 2016, and will put into operation in 2020. The total investment is nearly 700 million, and the instruments and facility will among the top level.

深圳药检人将秉承“严谨、责任、创新、奉献”的深圳药检核心价值观,牢记“做药品检验检测领域排头兵”的使命,不断提升检验能力、服务能力,为保障人民群众用药安全做出我们不懈的努力。

SZIDC will uphold our core value perception of “Preciseness, Responsibility, Innovation and Devotedness”, keep firmly in mind the mission of “being the pacesetter in the field of drug control”, improve their capability and service continuously, and make efforts to protect the people safe and effective medication.