GMP means Good Manufacturing Practice, which means good production practice in Chinese. This refers to a set of specifications that manufacturers follow in high-risk industries such as medicines and medical devices, aiming at ensuring the quality and safety of medicines and devices in the production process. GMP standards are very strict, covering every link of production, including the selection of raw materials, the environment of production workshops, and the operating specifications of personnel. It is an important measure to ensure product quality. Now many countries and regions have formulated their own GMP standards, which are widely used not only in the fields of medicine and medical devices, but also in other industries such as food industry.
1. GMP is the abbreviation of English GOOD MANUFACTURING PRACTICE, and Chinese means "good manufacturing practice". The World Health Organization defines GMP as a regulation that guides the production and quality management of food, medicine and medical products.
2.GMP is a set of mandatory standards applicable to pharmaceutical, food and other industries. It meets the hygiene quality requirements in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality management, etc. in accordance with relevant national laws and regulations, and forms operational norms to improve the hygiene environment of enterprises.
3. Simply put, GMP requires pharmaceutical, food and other production enterprises to 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, etc.) meets the requirements of laws and regulations.
4. Compared with the 98 version, the new version of GMP in China has made considerable progress in management and technical requirements. Especially in the production of aseptic preparations and APIs, high requirements are put forward. The new GMP is based on EUGMP and WHO2003, taking into account the domestic gap.
5. The new GMP certification has two time nodes: the production of sterile drugs such as blood products, vaccines and injections by pharmaceutical production enterprises should meet the requirements of the new GMP before December 31, 2022. The production of other kinds of drugs should meet the requirements of the new GMP before December 31, 2022. Enterprises (factories) that fail to meet the GMP requirements of the new version of drugs may not continue to produce drugs after the above-mentioned prescribed period.
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