GMP is the abbreviation of GOOD MANUFACTURING PRACTICE, which means "Good Manufacturing Practice" in Chinese. The World Health Organization defines GMP as the regulations that guide the production and quality management of food, drugs and medical products.
GMP is a set of mandatory standards for pharmaceutical, food and other industries, requiring companies to meet the health and quality requirements from raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control and other aspects of the relevant national regulations to form a set of operational practices to help companies improve the health of the corporate environment, timely detection of problems in the production process, to improve. Briefly, GMP requires pharmaceutical, food and other production enterprises should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the final product quality (including food safety and health) in line with regulatory requirements.
China's Ministry of Health in July 11, 1995 issued Wei drug hair (1995) No. 35 "on the development of drug GMP certification notice". Drug GMP certification is the state according to law on drug production enterprises (workshop) and drug varieties to implement GMP supervision and inspection and obtain recognition of a system. Although the international concept of pharmaceuticals includes veterinary drugs, only a few countries, such as China and Australia, are separating the GMP of human drugs from the GMP of veterinary drugs.
Drug GMP certification is carried out at the national and provincial levels, and according to the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China*** and the State", the drug supervision and management departments of the people's governments at the provincial level or above shall, in accordance with the "Good Manufacturing Practices for Pharmaceuticals" and the implementation measures and implementation steps stipulated by the State Council's drug supervision and management departments, organize the certification of drug manufacturers; those that comply with the "Good Manufacturing Practices for Pharmaceuticals" shall be issued with certification. Good Manufacturing Practice", issued a certificate of authentication. Among them, the production of injections, radiopharmaceuticals and biological products under the State Council drug supervision and management department of the certification of drug manufacturers, the State Council drug supervision and management department is responsible for. [