GMP is an abbreviation of Good Manufacturing Practices, which was initially written and formulated by six professors of Temple University in the U.S., and promulgated in the form of a decree by developed countries in Europe and the U.S. in the 60s and 70s of the 20th century, which was required to be widely adopted by pharmaceutical companies. Since 1988, China has formally promoted the GMP standard, which was revised twice, in 1992 and 1998.
GMP requires that systematic and standardized procedures must be formulated in terms of organization, personnel, plant, facilities and equipment, hygiene, validation, documentation, production management, quality management, product sales and recall, complaint and adverse reaction reporting, self-inspection, etc. Through the implementation of this series of procedures, in order to achieve a **** the same purpose:
Preventing the mixing of different medicines or their ingredients;
Preventing the mixing of different medicines or their ingredients;
Preventing the mixing of different medicines or their ingredients.
Prevention of cross-contamination by other drugs or other substances;
Prevention of errors and distortions in the transmission of measurements and information;
Prevention of accidents in which any raw and testing step is missed;
Prevention of arbitrary operation and non-compliance with standards and low limits of feed and other violations of the rules and regulations;
The main purpose of the development and implementation of GMP is to protect the consumer. The main purpose of the development and implementation of GMP is to protect the interests of consumers, to ensure that people use drugs safely and effectively; but also to protect drug manufacturers, so that enterprises have a law to follow, rules to follow; in addition, the implementation of GMP is the government and the law to the pharmaceutical industry's responsibility, and also China's accession to the WTO, the implementation of the need for quality assurance system of pharmaceuticals ---- because drug manufacturers who do not pass the GMP certification, may be rejected in the international trade of technology and technology. may be rejected outside the technical barriers to international trade.
It can be seen that the implementation of GMP is not only a drug manufacturer to the people's drug safety and effective highly responsible spirit of the concrete embodiment of the enterprise is an important symbol of the enterprise, but also an important guarantee of the competitiveness of enterprises and products, and international standards, so that the pharmaceutical products to enter the international market is a prerequisite. Therefore, it can be said that the implementation of GMP standards is the basis for the survival and development of pharmaceutical enterprises, through the GMP certification is the product to the world's "access card".