GMP is an acronym for GOOD MANUFACTURING PRACTICE, which in Chinese means "Good Manufacturing Practice". The World Health Organization defines GMP as the regulations that guide the production and quality management of food, medicines, and medical products.
The WHO began organizing the development of GMPs in the mid-1960s, and China began implementing them in the 1980s.China's GMPs were promulgated in 1988, and revised for the first time in 1992.
Over the past ten years, China's implementation of pharmaceutical GMP has made certain achievements, a number of pharmaceutical enterprises (workshops) have passed the pharmaceutical GMP certification and standards, and promote the pharmaceutical industry to improve the level of production and quality. However, from a general point of view, the implementation of drug GMP is not strong enough, part of the drug GMP is also urgent need to make corresponding changes.
Since its establishment on August 19, 1998, the State Drug Administration attaches great importance to the revision of drug GMP, has held a number of symposiums to listen to the views of all parties, especially the implementation of drug GMP main body - the views of drug manufacturers, and the organization of relevant experts to carry out the revision work.
"Good Manufacturing Practice" (revised in 1998) has been issued by the State Drug Administration, No. 9 Secretary of the Order, and August 1, 1999 shall come into force. After five years of revision, two public comments on the "Drug Manufacturing Quality Management Standards (2010 Revision)" (hereinafter referred to as the new version of the drug GMP) in March 1, 2011 shall come into force.
Development process
With the development of GMP, the international implementation of drug GMP certification. GMP provides the basic guidelines for drug production and quality management, drug production must comply with the requirements of GMP, the quality of the drug must meet the legal standards. China's Ministry of Health in July 11, 1995 issued Wei drug hair (1995) No. 35 "on the development of drug GMP certification work notice".
The GMP certification of drugs is a system for the implementation of GMP supervision and inspection of drug manufacturers (workshops) and drug varieties by the state in accordance with the law and obtaining recognition, which is an important part of the international trade in drugs and drug supervision and management, and a scientific and advanced management tool to ensure the stability of the quality of the drug, its safety and efficacy.
In the same year, the establishment of China Certification Committee for Drugs (China Certification Committee for Drugs, abbreviated as cccd). 1998, the State Drug Administration was established, 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 applications for the production of new drugs; approval of new drugs, only issued a new drug certificate, not issued a drug approval number. Strictly the approval of new drug production enterprises, not obtaining the certificate of GMP certification of drugs, shall not be issued to the "Drug Manufacturing Enterprise License".
Acquired GMP certification of enterprises (workshops), in the application for the production of new drugs, drug supervision and management departments to give priority to accept: until June 30, 1998 did not obtain GMP certification of enterprises (workshops), drug supervision and management departments will no longer accept applications for the production of new drugs.
To obtain GMP certification of drugs, drugs in the international drug trade, the State Council Drug Administration can apply for the export sales of drugs for the certificate: and can be in accordance with the provisions of the State's management of the price of drugs to the price department to reapply for 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 that have obtained the certificate of drug GMP certification and drugs produced by enterprises (workshops) that have obtained the certificate of drug GMP certification. Drug GMP certification of drugs, you can use the certification mark in the corresponding drug advertising, drug packaging and labeling, instructions.
Food GMP certification was initiated by the United States in the 1960s, and currently, in addition to the U.S. legislation has been mandatory implementation of food GMP, other countries, such as Japan, Canada, Singapore, Germany, Australia, China and other countries have yet to take a persuasive approach to counseling the industry to implement the automatic spontaneous.
Reference: Baidu Encyclopedia - Good Manufacturing Practice
Reference: Baidu Encyclopedia - GMP Certification