The benefits of applying for GMP certification for drug workshops

Simply put, GMP requires that food production enterprises should have good production equipment, reasonable production process, perfect quality management and strict inspection system to ensure that the quality of final products (including food safety and hygiene) meets regulatory requirements. GMP certification means that the Provincial Food and Drug Administration organizes GMP review experts to inspect all aspects of the enterprise, including personnel, training, plant facilities, production environment, sanitation, material management, production management, quality management, and sales management. , Drug gmp certification is a system that the state implements gmp supervision and inspection on drug production enterprises (workshops) and drug varieties and obtains approval according to law. It is an important content of international drug trade and drug supervision and management. ) is a scientific and advanced management method to ensure the quality stability, safety and effectiveness of drugs. After the establishment of the State Drug Administration in 1998, the Drug Certification Management Center of the State Drug Administration was established. In the same year, the China Certification Committee for Drugs (chinacertificationcommitteefordrugs, abbreviated as cccd) was established. The benefits of GMP certification provide a set of combined standards that must be followed for food production. GMP is a management that pays special attention to the implementation of food hygiene and safety in the production process. GMP requires that food production enterprises should have good production equipment, reasonable production process, perfect quality management and strict inspection system to ensure that the quality of the final product meets the requirements of regulations. The contents stipulated by GMP are the most basic conditions that food processing enterprises must meet, and are the preconditions for the development and implementation of other food safety and quality management systems. Provide a basis for supervision and inspection for health administrative departments and food hygiene supervisors, and provide a basis for establishing international food standards, such as: HACCP, BRC, SQF, to meet customer requirements and facilitate the international trade of food. , The requirements for packaging materials are more stringent. It is helpful for food production enterprises to adopt new technologies and new equipment to ensure food quality. Provide important teaching materials for food production and management personnel to understand the particularity of food production, thereby producing a positive working attitude, inspiring a spirit of high responsibility for food quality, and eliminating bad habits in production. 'GMP' is the abbreviation of Good Manufacturing Practice in English, and it means 'Good Manufacturing Practice' or 'Good Manufacturing Standard' in Chinese. It is a set of mandatory standards applicable to the pharmaceutical, food and other industries. It requires enterprises to meet the hygienic quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control, etc., and form a set of operable The operating specifications help enterprises to improve the sanitary environment of the enterprise, find out the problems existing in the production process in time, and make improvements. With the development of gmp, the international implementation of drug gmp certification. gmp provides basic guidelines for drug production and quality management, drug production must meet the requirements of gmp, and drug quality must meet legal standards. On July 11, 1995, the Ministry of Health of our country issued a notice on the development of GMP certification of medicines by Wei Yaofa (1995) No. 35. Since July 1, 1998, the Ministry of Health will not accept applications for the production of new drugs for enterprises that have not obtained the drug gmp certification; if a new drug is approved, only the new drug certificate will be issued, and the drug approval number will not be issued. Strictly examine and approve new drug production enterprises, and those who have not obtained the drug gmp certification shall not be issued a 'drug production enterprise license'. For enterprises (workshops) that have obtained the drug gmp certification, when applying for the production of new drugs, the drug supervision and management department will give priority to accepting them. The application for new drug production will be accepted again. For drugs that have obtained the drug gmp certification, when participating in international drug trade, they can apply to the drug regulatory department of the State Council for a certificate for export sales of drugs: they can re-apply to the price department for approval of the drug price in accordance with the national regulations on drug price management . Pharmaceutical business units and medical units at all levels should give priority to purchasing and using drugs that have obtained GMP certification for drugs and drugs produced by enterprises (workshops) that have obtained GMP certification. Drugs certified by GMP can use the certification mark on the corresponding drug advertisements, drug packaging and labels, and instructions. 'Good Manufacturing Practice' (GoodManufacturePractice, GMP) is a regulation that guides drug production and quality management. The World Health Organization officially announced the GMP standard in November 1975. Internationally, the concept of drugs includes veterinary drugs, and only a few countries, such as China and Australia, separate GMP for human and veterinary drugs. Food gmp certification was initiated by the United States in the 1960s. At present, except for the United States, which has legislated to enforce food gmp, other countries such as Japan, Canada, Singapore, Germany, Australia, China and other countries still adopt the method of persuasion to automatically implement it. The 'Drug GMP Certificate' is valid for 5 years. The 'Pharmaceutical GMP Certificate' for newly established drug manufacturing enterprises is valid for one year. Drug manufacturers should re-apply for drug GMP certification 6 months before the expiration of the validity period. A newly established pharmaceutical production enterprise shall apply for a re-examination 3 months before the expiration of the 'Drug GMP Certificate'. After passing the re-examination, a 'Drug GMP Certificate' with a validity period of 5 years will be issued.

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