Guangdong Institute for Drug Control (GDIDC) was first established in November 1962, and authorized in 1983 as Guangdong Coastal Institute for Drug Control for the People’s Republic of China by the Ministry of Health. In 1992, it was permitted to set up Guangdong Institute of Drug Quality as an addition by Guangdong Provincial Government. In 1999, it was authorized by the State Drug Administration to assume the responsibility for the lot release of human albumin and it was transferred as a whole unit to Guangdong Food and Drug Administration from the Health Bureau of Guangdong Province in the process of organizational reform of drug administration in 2000. It became the first in the system reform of the national drug control in 2004 to implement the administrative system of civil servants.

    GDIDC is a legal, non-profitable organization of drug control, permitted by Guangdong Provincial Government and established on the basis of Drug Administration Law of P.R.C. It assumes the responsibilities for the drug registration, supervision and inspection before and after the drugs are put on the market and for import drug coast control. Meanwhile, it also undertakes part of the state-authorized affairs for lot release and quality control of biological products. It is under the instruction of the National Institute for the Control of Pharmaceutical and Biological Products, Chinese Pharmacopoeia Commission, Center for Drug Evaluation, State Food and Drug Administration, National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products P.R.C, China National Accreditation Board for Laboratories and the Guangdong Bureau of Quality and Technical supervision. It provides the instructions in drug control and methodology research to the institutes for drug control in the cities and towns in Guangdong Province, and to the organizations of drug manufacturing, distribution, use, research and education, including the quality control of chinese material medica, traditional chinese medicine preparation, chemicals and antibiotics, biochemicals, biological products and health foods.

    There are six technical departments of traditional Chinese medicine, chemistry, antibiotics, biological and biochemical products, pharmacology and research and then there are five functional sections: executive offices, human ressours & security, finance, business, and quality control. The authorized number of the staff for the Institute is 120 and at present we have a staff of 109: 30 with senior technical titles, 32 with medium technical titles, 5 with Ph.D, 31 with master degree, 47 with bachelor degree, in addition to 43 registered technicians. We have a panel of over 20 experts such as members of Chinese Pharmacopoeia Commission, members of National Committee on Drug Evaluation, members of National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products, assessors of National Accreditation Board for Laboratories, assessors of National Metrology Certification, assessors of Guangdong Provincial Metrology Certification, members of Guangdong Provincial committee on Drug Evaluation, members in-chief of related subjects of Chinese Pharmaceutical Association Guangdong Branch, guest professors and tutors of postgraduate students.

    GDIDC has always attached great importance to the construction of the quality system. In 1990, our institute successfully passed the accreditation concerning measurement conducted by Guangdong Provincial Bureau of Quality and Technical Supervision (GDPBQTS) and the accreditation of laboratories by the Ministry of Health in 1996. In 1998 we got the certificate of sanitary animal rooms issued by Guangdong Provincial Committee of Science and Technology (GDPCST) and the second-class state certificate of overall archives maintenance. In 2004, we obtained the certificate of the SPF-class animal rooms issued by GDPCST. In 2005, our laboratories were recognized as China National Accreditation Laboratory (CNAL No.L2000, including the following three categories and 222 items: medicine, biotical products and air quality) by the China National Accreditation Board for Laboratories and successfully passed the re-accreditation by GDPBQTS. The Quality System Document put the first edition of Quality (Management) Manual into effect in 1990 and the fifth edition gradually came into existence through the combination with ISO/IEC17025 principles and modern administrative theory. Accordingly, all the technical and special-type work staff are required to have necessary certificates before they can work. The technical department heads should be senior technicians. The management principle is “positions at different levels, mutual supervision, one position with double responsibilities, and two persons in charge”. Under the leadership of the head, the institute has three divisions of its work: technology operation, service support and quality supervision which builds up a network of complete quality assurance for decision-making, execution and supervision, thus creating forty two positions of three categories for those who are responsible for administration, operation and examination. As a result of this, a scientific, impartial, high-graded and highly efficient administration system has been established.

    Top manager

    Quality Supervision－Quality Control Section

    Technical support－Executive Offices, Human Resource and Security Section, Computer Section, Finance Section

    Technical Operation－Business Section, Traditional Chinese Medicine Dept., Chemistry Dept., Antibiotics dept., Biological products& Biochemistry Dept., Pharmacology dept., Research dept.

    In the recent years, our institute has focused on the control of the quality of the drugs and the improvement of the drug monitoring techniques. We have accepted 81 contract about research projects, undertaken 8 from the State Administration of Traditional Chinese Medicine and the Provincial Administration of Traditional Chinese Medicine, obtained two second and third Science Progressive Prizes respectively, had 111 papers published, joined the work of drafting, revising, checking and compiling Chinese Pharmacopoeia and its alliance, National Standard of Drugs, and Guangdong Provincial Standard of Chinese Medicinal Materials etc. In 2004 we successfully established the fast detection method of sidenafil citrate added illegally in nutritious food and traditional chinese medicine preparations, which was technically authenticated at the provincial level.

    GDIDC is located at No.2, Jinbuli, Huifuxi Road, in the capital city, also named Flower City, of Guangdong Province, between the White Cloud Mountain and Pearl River, a location where there are many traditional well-known tourist attractions. To the east is Wuxianguan Temple, where celestial beings had once been to, to the north is the Temple of Bright Filial Piety, which once promoted the morals and manners while to the west is the Ancestral Temple of the Chen Family, which accumulated the Cantonese architectural essence. The main premises are two buildings on the north and south and attached to each other, with excellent environment, reasonable structure, good ventilation and conditions of getting light from the outside. The whole area involved is totally 6,700m2, in which there are two different separated regions. One of them, totally 5100m2, is for laboratory area while the other, totally 1600m2, is for the office area. Subsidiary to that are the rooms of computers, specimen, comprehensive records and a library. In addition, there are SPF-class animal room and sanitary animal room, a sterile room, microorganism test room, enzyme linked immunoassays room, sterile sampling room, storage sample room, cold storage, underground storehouse, conference room and multifunctional hall. There is also an additional office area, approximately 2000m2, for future use, and some 800m2 rented offices.

    GDIDC is well-and-fully equipped with all necessary installations: over 130 kinds and 460 sets, totally worth more than 41 millions. The institute possesses 37 sets of high performance liquid chromatography(HPLC), 16 sets of gas chromatography(GC), liquid chromatography-mass spectrometry(LC-MS), capillary electrophoresis, near infrared spectrometer, infrared spectrometer, atomic absorption spectrophotometer, ultraviolet spectrophotometer, fluoremetry spectrophotometer, thin layer chromatographic scanner, automatic multi-parameter analyzer for clinical chemistry, automatic Tecator Kjeltec system, automatic dissolution tester, automatic titrator etc. In brief, the equipments almost include all the advanced, precision and high-tech ones required by Chinese Pharmacopoeia and are developing toward specialization, automation and computerization.

    An information management system has been independently developed with which a series of sub-systems have been set up and improved for finance, human resource, logistics, office administration and laboratories. The Institute’s LAN and website have been established, and the Labortory Information Management System (LIMS) has been developed .We aim at modernizing our work of drug control by means of informatization.

    Apart from the fact that 13 old party members who have retired have formed a party branch, there are 58 Communist party members at the institute which belong respectively to two functional party branches and three laboratory party branches. Under the leadership of the Communist party, the members of the Youth League cooperate with each other. The political instruction is often implied in the recreational activities, thus creating the institute’s culture, one that pursues both excellent skills and healthy and active ideology, actively creating such constructive atmosphere as one party branch acting as one stronghold, one party member as one model, one department as one window, one group as one strength, one leader as one example, and one employee as one competent member of the staff.

    GDIDC recombined resource of drug control institutes of whole province in the process of organizational reform of drug administration in 2000. There are one provincial level, two subprovincial level and 20 level in the cities and towns (including the section of Shunde ) in Guangdong Province. GDIDC not only promote co-development of drug control institutes of whole province but also exploit territorial and international business. In 2003, GDIDC was recognized by the Ministry of Health of Hong Kong Special Executive District as one of the Hong Kong registered inspection institutes for the traditional chinese medicine prepartions. In 2004, our institute signed the cooperative agreement in terms of drug control with the institutes for drug control in the nine pan-Pearl River Delta provinces and district.

    Based on the spirit of “being humanity-centered, regulation-governed, open-minded and enterprising and perfection-seeking” and in according with the principle of “Customers First, Service Sincere” , GDIDC is developing towards the goal of standardization, automation, informatization and integration by means of mechanism, environment, culture, approaches, technology, and innovation in terms of service in order to become the first-class institute for drug control in China with international levels and criteria, and to be the strong technical support for the public who can use the medicines with security, for the sound development of medical economy as well as for drug control and supervision with efficient and powerful enforcement.