Shenzhen institute for drug control was first established in 1982., It was permitted to set up Shenzhen Testing Center of Medical Devices in 2003. As a public service unitsupervised by Shenzhen Food and Drug Administration, executives the quality inspection of drug, medical devices, health products and cosmetic etc. It is a legal and professional organization.
    Seven departments have been set in the headquarter. There are three functional departments: Administration office, Business technology dept. and QC dept.; otherwise there are four technical departments: Chemistry dept., Traditional Chinese Medicine dept., Antibiotics dept. and Biology determination dept.. The Testing Center of Medical Devices has three departments include general Business dept., Passive devices test dept. and Active devices test dept.. And the passive device test dept. can be divided into chemistry test section, physical test section and biology test section; the active device test dept. can be divided into electrical device safety & performance test section, electrical ambient & electromagnetism compatibility test section. We have 57 formal staff at present, 50 of them are professional technical staff: 7 are professor of pharmacy, 13 are associate- professor of pharmacy, 20 are Pharmacist-in-charge; 47 with bachelor or above degree, 3 with PhD degree, 11 with master degree. We have a panel of experts such as members of national health foods, members of national development and reform commission, members of China national accreditation service for conformity assessment, assessors of Guangdong provincial metrology certification, and members of pharmaceutical analysis of Chinese Pharmaceutical Association Guangdong Branch, guest professors and supervisors of postgraduate students.
     In 1990, our institute successfully passed the accreditation concerning measurement conducted by Guangdong Provincial Bureau of Quality and Technical Supervision (GDPBQTS), and in 1995, 2000, 2003 passed the re-accreditation by GDPBQTS. In June 1996, we passed the accreditation of laboratories by Ministry of Health. In May 2004, our laboratories were recognized as China National Accreditation Laboratory. In Nov. 2004, it was approved China National Accreditation Laboratory by the National Accreditation Committee for Laboratories included nine categories and 286 items of foods, medicine, material of medicine packages, materials and excipient, materials and products of macromolecule in medical iatric,rubber condom, cleanliness area, cleaning room (environment), the Biont Diagnostic Reagent in Vitro, electron instruments of medical device etc.
    The working area of the headquarter is 3098 m2, and 2800m2 are used for business purpose; the working area of the testing center of medical devices is 1480m2, and 784m2 are used for business purpose. It is quipped with several laboratories for physical, chemical, instrumental, electronic, micro-biological, and animal etc., and some sterile labs, reserved room and herb specimen room. All the instruments using in lighting, aeration, air decontaminate, limber, sullage evacuate, temperature and humidity control, aseismatic and noises control etc., are fixed for the requirements of testing environment. New institute will be located at Shenzhen High-tech Industries Park. The building area is over than 15000 m2, and invested over than 85.7 millions RMB.
    Our institute is well-and-fully equipped with all necessary installations of over 500 sets, including Liquid chromatography-Mass spectrometry (LC-MC), Gas chromatography-Mass spectrometry (GC-MC), High performance liquid chromatography (HPLC), gas chromatography (GC), Medium/Near infrared spectrometer, Thermal analyzer, Visible/Ultraviolet spectrophotometer, Atomic absorption spectrophotometer, Thin layer chromatography etc.. The precision and parameters of the equipment can be fulfilled the requirements of testing work. Totally worth more than 40 millions, among them more than 30 millions are equipment and apparatus.
    The average accomplished items for drug scheduled inpection, random inspection, commissioned inspection, quality standard recheck and technical service items are over 4000 batches in recent years. The institute not only focus on the testing work but also develop and use technique resources to expend the research and development, teaching or training work. In recent years, several decadal research projects were undertaken from the state, provincial and civic, had approximate 100 papers published and had taught college interns and advanced studies people about one hundred.
    During the execution of Drug Administration Law, Measurement Law etc, our institute serve the government to make the supervision science and efficiency, serve the medical economy to develop healthly, serve the people to use drug in an efficiency way and use these as the tenet. Following by the ‘science and justice, quality and efficiency’ as the quality policy, based on the spirit of ‘being humanity-centered, regulation-governed, improvement-persisted, innovation-ceaseless’, fulfill thescientific view of development. By the continuous innovation on system, organization mechanism, and technique, set up the ability of testing, research &development, service, innovation, the insititute will be developed to a more science, regulation and information way for the aim of establish a first-class pharmaceutical analysis laboratory in domestic and international.

 

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