What is gmp standard?

GMP (Good Manufacturing Practice) GMP means "Good Manufacturing Practice" or "Good Manufacturing Standard" in Chinese.

1, GMP is a set of mandatory standards applicable to medicine, food and other industries, which requires enterprises to meet the hygiene quality requirements in terms of raw materials, personnel, facilities and equipment, production technology, packaging and transportation, quality control, etc. according to relevant national laws and regulations, and form a set of operating specifications to help enterprises improve the hygiene environment, and find out the problems existing in the production process in time and make improvements.

2. In short, GMP requires pharmaceutical, food and other production enterprises to have good production equipment, reasonable production technology, perfect quality management and strict testing system to ensure that the final product quality (including food safety and hygiene) meets the requirements of laws and regulations.

The emergence of gmp is related to thalidomide, which shocked the world. Thalidomide is a sedative. In the late 1950s, it was produced by Glen Sunan Pharmaceutical Factory, the former Federal Republic of Germany, and was used to treat vomiting of pregnant women. In the six years after its sale, it has caused more than 65,438+02,000 abnormal fetuses and 65,438+0300 polyneuritis in 28 countries including the Federal Republic of Germany and Japan. At that time, the United States did not approve the import "reaction stop", which was basically unaffected. However, the serious consequences of this incident caused anxiety in the United States. The American public is strongly concerned about drug supervision and drug regulations, which led to a major revision of the Food, Drug and Cosmetics Act by Congress. The amendment 1962 greatly strengthened the enforcement of the drug control law in the following three aspects:

1, requiring pharmaceutical companies to prove not only the effectiveness of drugs, but also the safety of drugs.

2. Require pharmaceutical companies to report adverse drug reactions to fda.

3. Require pharmaceutical enterprises to implement pharmaceutical production and quality management standards. 1963, the US Congress promulgated the world's first gmp. Gmp is the abbreviation of English good manufacturing practice. Literally translated as "good manufacturing practices", the word "manufacturing" contains double meanings of production and quality management. In addition, gmp has become the basic principle of international drug production and quality management, and it is a systematic and scientific management system, so the translation of "good manufacturing practice" is closer to the original intention.