深圳市药品检验研究院

2018-09-05

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深圳市药品检验研究院(深圳市医疗器械检测中心)成立于1982年7月,是法定的药品、医疗器械专业性检验、科研机构,检验领域覆盖药品、特殊食品、化妆品、医疗器械、药包材、洁净区(室)环境、实验用水等8大类产品,检验数据国际互认。目前,业务范围包括:WHO等国际组织委托检验,进口药品检验,新产品注册检验,国家、省、市政府监督性、评价性抽查检验及应急检验。同时,围绕检验新技术新方法,国际药品标准、国家标准,补充检验方法,快筛、快检技术,仿制药一致性评价等开展科学研究工作。

Shenzhen Institute for Drug Control (SZIDC) (Shenzhen Testing Center of Medical Devices (STCMD)) was established in July 1982. SZIDC is a legal professional inspection and scientific research institution for medicines and medical devices. The inspection area covers 8 categories of products, including medicines, special food, cosmetics, medical devices, packaging materials for pharmaceutical use, clean areas (rooms) environment and experimental water. The inspection data have been by many countries, regions and international organizations. Currently, the business scope includes testing entrusted by international organizations such as WHO, testing of imported drug, registered testing for new product, supervision/evaluation inspection and emergency inspection. Scientific research has been carried out on new testing techniques and methods, international pharmaceutical specifications, national specifications, supplementary testing methods, rapid screening/ inspection techniques, and generic drug consistency assessment.

我院是国家口岸药品检验所,国家博士后科研工作站设站单位,是港澳地区中成药注册检验机构、保健食品注册检验复核检验机构、特殊食品验证评价技术机构、化妆品行政许可检验机构、国产非特殊用途化妆品备案检验机构、医疗器械监督检验注册检验机构、食品复检机构。2018年5月,获批成为世界卫生组织药品质量控制预认证(WHO-PQ认证)实验室,成为全球第46家、中国第2家、地方第1家“WHO-PQ认证”实验室。

SZIDC has a number of inspection qualifications, such as the Shenzhen Port Inspection Institute of the People's Republic of China, the National Post-doctoral Workstation, Registered Testing for Chinese Patent Medicine from Hong Kong and Macao, Registration/Inspection/Re-inspection Organization for Health Food, Technical Organization for Verification and Evaluation of Special Food Products, Administrative Licensing Inspection Organization for Cosmetics, Registration Inspection Organization for Domestic Non-special Purpose Cosmetics, Supervision/Registration Inspection Organization for Medical Device, Re-inspection Institution for Food. SZIDC officially became the WHO prequalified Quality Control Laboratory on May 1, 2018, which is the 46th in the world, the second in China and the first local WHO prequalified Quality Control Laboratory.

我院现有实验室总建筑面积15000㎡,配备核磁共振波谱仪、X-射线粉末衍射仪、液质联用仪、气质联用仪、电感耦合等离子体质谱仪(ICP-MS)、近红外拉曼光谱仪、全自动微生物基因指纹鉴定系统、流式细胞仪、AU680全自动生化分析仪、扫描电镜等各类大型精密仪器2684台/套。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、无源医疗器械检测部、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7大职能部门。

The total construction area of SZIDC is 15, 000 m2. The laboratory is equipped with 2684 instruments, including NMR, XRD, UPLC-MS/MS, GC-MS, ICP-MS, NIR, FCM, RP, and SEM. SZIDC has 9 testing laboratories for Chemical Drug, Traditional Chinese Medicine, Health Food and Cosmetics, Pharmacology and Toxicology, Microbiology, Analysis and Testing Research, Non-active Medical Devices, In-vitro Diagnostic Reagents, Active Medical Devices, and 7 functional departments-Executive Office, Business and Technology Department, Quality Management Department, Equipment Purchasing and Maintenance Department, Supervision Management Office, Information Technology Department, Medical Devices General Business Department.

现有工作人员200余名,其中博士、硕士80余人,高级以上职称50余人,享受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70余人次。

SZIDC has more than 200 employees at present. Among them, more than 80 have doctorates or master's degree. There are more than 50 employees have a senior professional title. The expert group includes expert enjoying special allowances from the State Council and Shenzhen Municipal Government, members of the Chinese Pharmacopoeia Commission and Standardization Technical Committees, national health-food review experts, laboratory auditors of CNAS, High-level professional in Shenzhen (local-level), as well as part-time doctor and master supervisors from several domestic universities.

我院围绕“质量化、标准化、品牌化、国际化”的发展战略,按照“最优秀的检验队伍、最先进的检验装备、最科学的检验方法、最完备的检验体系”的工作要求,在全国率先开发应用实验室信息化管理系统(LIMS),实现从样品受理、分发、数据记录、审核、签发全过程的电子化实时监控。

Around the "Quality, Standardization, Branding and Internationalization" of development strategies, and in accordance with "the best testing team, the most advanced testing equipment and scientific testing method, the most complete testing system" of the work requirements, we take the lead in developing and applying laboratory information management system (LIMS) in China , which realizes electronic real-time monitoring from sample acceptance, distribution, data record, audit to issue.

应用大数据分析,构建集实验室信息化管理、科学数据管理、数据分析、综合办公管理、资产管理5大系统为一体的“智慧药检”系统平台。

Applying big data analysis, we have built a “Smart SZIDC” system platform integrating laboratory information management, scientific data management, data analysis, comprehensive office management and asset management.

构建起“621”重大技术支撑平台暨“1个国际级技术平台—WHO-PQ认证实验室”,“2个国家级技术平台—中华人民共和国深圳口岸药品检验所、国家博士后科研工作站”,“6个市级技术平台—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等”。

We have built a “621” major technical support platform, including 1 international technology platform- WHO prequalified Quality Control Laboratory, 2 national technology platforms- Shenzhen Port Inspection Institute of the People's Republic of China and National Post-doctoral Workstation, 6 local technology platforms-such as Key Laboratory of Pharmaceutical Standard Research, and Key Laboratory for Chinese Materia Medica Resources (Lingnan region) Development and Application.

与美国哈佛大学医学院、迈阿密大学、内布拉斯加大学、田纳西大学,香港科技大学、澳门大学、清华大学、中国药科大学、暨南大学、沈阳药科大学等国内外高校开展交流合作。

We have established fruitful collaboration mechanism with Harvard Medical School, University of Miami, University of Nebraska, University of Tennessee, Hong Kong University of Science and Technology, University of Macau, Tsinghua University, China Pharmaceutical University, Jinan University, Shenyang Pharmaceutical University, etc.

编制中药材标本电子书10册,涉及186科1135种岭南地区中药材,用信息化的手段为中药材的鉴定及后续开发奠定基础;

We have prepared 10 volumes of e-books of Chinese herbal medicines, involving 1135 kinds of Chinese herbal medicines from 186 families in Lingnan area, and laid the foundation for the identification and subsequent development of Chinese herbal medicines by means of informationization.

率先在国内开发应用健康产品非法添加数字化识别系统,可开展保健食品、化妆品中10大类成分共500余种禁用成分的筛查。

We developed and applied the digital identification system for the illegal addition of health products in China innovatively, which can carry out the screening of more than 500 prohibited ingredients in 10 categories of health food and cosmetics.

2009年-2018年,承担10个品种的《国际药典》质量标准起草,已完成的9个被收录;完成4个品种全球基金项目起草、复核;完成784个质量标准起草复核;建立48项非标方法;获批5个补充检验方法;获批15项专利授权,其中,2项获美国专利商标局授权;成功开发4种快筛快检产品;在国内外刊物发表600余篇学术论文,其中SCI论文38篇,累计影响因子97.8;荣获广东省科学技术奖、深圳市科技创新奖等市级以上各类奖励70余项。

Since 2009, 10 monographs were elaborated for International Pharmacopeia (9 adopted) , 4 monographs were developed/verified for Global Fund, 784 monographs were developed/verified for Chinese Pharmacopoeia or national pharmaceutical specification, 48 nonstandard and 5 supplementary testing method were established. 15 patents were authorized, which including 2 United States Patents. 38 SCI papers were published (Total IF=97.8). SZIDC has been awarded more than 70 different provincial and municipal sci-tech awards.

我院新开工建设的总投资8.17亿元(不含检测设备),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”将是全国药检系统中单体建筑面积最大、设施设备领先、符合药物非临床研究质量管理规范(GLP)的智能化检验、科研综合实验室,将于2020年落成使用。

The under construction “Shenzhen Medical Device Testing and Biomedical Safety Evaluation Center” with a total investment of 0.87 billion RMB (instrument not included) and a construction area of 46,000 m2 will be an intelligent inspection and scientific research laboratory with the largest single building area, leading equipment in the national drug testing system. The laboratory will meet the requirements of Good Laboratory Practice of medicine (GLP) and will be put into use in 2020.

届时深圳药检院将搭建起集药品、医疗器械检验检测,标准制修订及新药、新型医疗器械(基础研究、动物实验、临床研究)研发为一体的技术支撑平台。

At that time, SZIDC will set up a technical support platform integrates medicine and medical device testing, specification development/verification and innovative medicines, new medical device R&D (basic research, animal experiment, clinical research).

面向未来,深圳药检院将秉承“严谨、责任、创新、奉献”的深圳药检核心价值观,按照“建设国际一流、国内领先实验室”的目标愿景,不断提升“服务政府监管、服务产业发展、服务公众用药安全”的技术支撑能力。

In the future, SZIDC will be adhering to the "Preciseness, Responsibility, Innovation and Dedication" of the core values, according to the goal of "construction of the domestic first-class, international leading laboratory", improve technical support ability of "Service for government supervision, Service for development of bio-pharmaceutical industry, Service for the public medication safety service" constantly.

深圳市药品检验研究院

Shenzhen Institute for Drug Control

2018年7月

2018.7