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药检所

深圳市药品检验研究院、深圳市医疗器械检测中心

  • 更新日期:2022-04-27
  • 查看次数:996

详细介绍

深圳市药品检验研究院(以下简称“深圳药检院”)原为深圳市药品检验所,成立于1982年7月。2003年增设“深圳市医疗器械检测中心”。2015年更名为“深圳市药品检验研究院”。2017年获批“中华人民共和国深圳口岸药品检验所”。2018年成为全球第46家、中国第2家、地方第1家世界卫生组织药品质量控制认证(WHO-PQ认证)实验室。2020年成为国内首家联合国药品检测全球长期合作实验室。

Shenzhen Institute for Drug Control (“SZIDC”) was established in July 1982. In 2003, Shenzhen Testing Center of Medical Devices (STCMD) was additionally opened. In 2015, the Chinese name of the Institute was changed. In 2017, the SZIDC was approved as the “Shenzhen Port Drug Inspection Institute of the People’s Republic of China”. In 2018, it officially became the WHO Prequalified (WHO-PQ) Quality Control Laboratory, which is the 46th in the world, the second in China and the first local WHO-PQ Quality Control Laboratory. In 2020, it became China’s first global drug testing laboratory of the United Nations Development Program (UNDP) for long-term cooperation.

深圳药检院是法定的集药品、医疗器械、化妆品检验和科研于一体的专业检测机构,业务领域涵盖国家、省、市监督、评价、应急检验,进口检验,国际组织委托的检验与科研,产品质量标准制修订与检验研究,培训教育及技术检查,生物医药产业发展技术平台建设等。实验室建筑面积6.2万平方米,各类大型精密检验仪器5000余台/套,固定资产14.4亿元。拥有WHO-PQ认证专家、欧洲药典委员会委员、国务院政府特殊津贴、国家药典委员会委员、国家级省级评审检查员、博士生及硕士生导师等各类专家群体。

The SZIDC is a legal professional organization for testing and scientific research of medicines, medical devices and cosmetics. Its main business domains include: national, provincial and municipal supervision/evaluation/emergency testing; import testing; testing and scientific research tasks entrusted by international organizations; revision and inspection of product quality standards; training, education, and technical inspection; construction of technology platforms for the development of the biomedicine industry. It has a total building area of 62,000 m2 for laboratories, with 5,000 sets of various large precision testing instruments, and fixed assets of RMB 1.44 billion. At present, a group of various experts are employed, including WHO-PQ certified experts, members from the European Pharmacopoeia Commission (EPC), experts enjoying special allowances from the State Council, members from the Chinese Pharmacopoeia Commission (CPC), national and provincial assessors and inspectors, supervisors of doctoral students and postgraduate students.

通过实施“质量化、标准化、品牌化、国际化”发展战略,搭建起国际、国内平台基地30余个,建立LIMS系统为核心的实验室信息化管理系统,实现从样品受理、分发、数据记录、审核、签发涉及人、机、料、法、环、测等全过程的信息化动态管理。全国率先开发中药检验自动化、信息化、智能化前处理系统,填补了国内中药检验与智能化相结合的空白。实验室先后通过CMA、CNAS、WHO等国内外权威部门和国际组织的认证认可检查,检验检测软硬件条件、综合实力位居全国药检系统第一方阵,检验技术能力、科研工作、实验室体系管理、信息化建设等四大领域工作走在行业前列。

By adhering to the “quality-oriented, standardized, branded and international” development strategies, the SZIDC has set up more than 30 international and domestic platforms and bases, and created the laboratory information management system with the LIMS system as the core, enabling the information-based dynamic management of the entire process from sample acceptance, distribution, data record and audit to issuance concerning 5M1E (man, machine, material, method, measurement and environment). It is the first in China to develop an automated, intelligent and information-based pretreatment system for testing of traditional Chinese medicines, filling the gap in China in the combination of TCM testing and intelligence. The laboratory has successively been certified and accredited by CMA, CNAS, WHO, other Chinese and foreign authoritative organizations, and international organizations. The SZIDC is at the forefront the industry in four major aspects - testing technical competence, scientific research, laboratory system management and information construction, with its inspection and testing software and hardware and comprehensive strength ranking top in China’s drug testing system.

遵循“检验依托科研,科研提升检验”的方针,通过多年的发展,取得多项开创性科研成果。是地方药检机构首家国家博士后科研工作站设站单位,立足培养药检领域高层次人才;获批“中药质量研究与评价重点实验室”、“化妆品监测评价重点实验室”、“仿制药评价生物等效性重点实验室”3个国家药品监督管理局重点实验室,建成9个省级重点实验室。完成13项《国际药典》、全球基金药品质量标准研究,制修订产品质量标准700余项;获授权国家发明专利、美国专利、PCT专利20项;获省级一、二、三等科技进步奖及专利奖7项;其他奖励100余项。与联合国、世界卫生组织以及美国、德国、日本、香港、澳门等国际组织、知名院校开展了多领域、深层次的合作交流。

Committed to the guideline of “basing testing work on scientific research and improving testing work through scientific research”, the SZIDC has made many groundbreaking achievements in in scientific research after years of development, and is the first among local drug control institutions to set up the national post-doctoral workstation, focusing on the training of high-level talents in drug testing domain. It has been approved by the National Medical Products Administration as the “Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine”, “Key Laboratory for Bioequivalence Research of Generic Drugs” and “Key Laboratory for Monitoring and Evaluation of Cosmetics”, and has established 9 provincial key laboratories. Moreover, the SZIDC has completed the research on quality standards for 13 species included in the International Pharmacopoeia and Global Fund, developed and revised more than 700 product quality standards; obtained 20 national invention patents, US patents and PCT patents, 7 provincial awards for progress in science and technology and patent awards (first, second and second place), and more than 100 other awards. It has conducted deep exchanges and cooperation in many fields with the United Nations, the World Health Organization, other international organizations and prestigious universities in the United States, Germany, Japan, Hong Kong and Macau.

“十四五”期间,深圳药检院将以习近平新时代中国特色社会主义思想为指导,坚持高质量发展理念,抓住“双区”建设重大历史发展机遇,以“大开放、大平台、大合作”的方式,持续提升药品全生命周期监管检验能力和生物医药产业发展技术平台能力,在支撑政府监管、促进产业发展、保障公众健康等方面谱写新的篇章。

During the “14th Five-Year Plan” period, the SZIDC, under the guidance of President Xi Jinping’s “Thought on Socialism with Chinese Characteristics for a New Era” and in line with the “high-quality development” philosophy, will strive to seize the major historical opportunity created by the construction of Guangdong-Hong Kong-Macao Greater Bay Area and the Pilot Demonstration Area of Socialism with Chinese Characteristics, and continue to seek constant improvement in its “drug lifecycle supervisory testing capability” and “technical platform capability in biomedicine industry development”, to write a new chapter in supporting government supervision, promoting industry development, and protecting public health.