"GMP" is an abbreviation of good manufacturing practice, which means "Good Manufacturing Practice" or "Good Manufacturing Practice" in Chinese, and is an autonomous management system that pays special attention to product quality and health and safety in the manufacturing process. It is a set of mandatory standards applicable to the pharmaceutical, food and other industries, requiring companies to meet health and quality requirements from raw materials, personnel, facilities and equipment, production processes, 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.
With the development of gmp, the international implementation of the drug gmp certification. gmp provides the basic guidelines for drug production and quality management, drug production must comply with the requirements of the gmp, the quality of drugs must comply with the statutory standards. 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, is an important element of international drug trade and drug supervision and management, but also to ensure the stability of the quality of medicines, safety and efficacy of a scientific and advanced management tools. In the same year, the establishment of China Drug Certification Committee (China?certification?committee?for?drugs, abbreviated as cccd). 1998 State Drug Administration was established after the establishment of the State Drug Administration Drug Certification Management Center. Since July 1, 1998, did not obtain the certificate of drug gmp certification of enterprises, the Ministry of Health will not accept the production of new drug applications; approval of new drugs, only issued a new drug certificate, not issued a drug approval number. Strictly the approval of the new start-up drug production enterprises, the failure to obtain the certificate of drug gmp certification, shall not be issued to the "Drug Manufacturing Enterprise License".
Acquisition of drug gmp certificate of authentication of the enterprise (workshop), in the application for the production of new drugs, drug supervision and management departments to be given priority in acceptance: until June 30, 1998 did not get the drug gmp certificate of authentication of the enterprise (workshop), drug supervision and management departments will no longer accept the application for the production of new drugs. Obtained gmp certification of drugs, drugs in the international drug trade, the State Council drug supervision and management department can apply for export sales of drugs for the certificate: and can be in accordance with the provisions of the state price management of drugs to the price department to re-apply for the approval of the price of the drug. Drug business units and medical units at all levels should give priority to the purchase and use of drugs and pharmaceutical gmp certification certificate of the enterprise (workshop) to obtain gmp certification of the production of drugs. Drug gmp certified drugs, can be used in the corresponding drug advertising, drug packaging and labeling, instructions on the use of the certification mark.
Food gmp certification was initiated by the United States in the 1960s, the current in addition to the U.S. has been legislated for the mandatory implementation of food gmp, others such as Japan, ? Canada, Singapore, Germany, Australia, China and other countries are still taking persuasion? The counseling industry to implement automatically and spontaneously.