What is GMP

The GMP standard («Good Manufacturing Practice») - a system of measures and regulations to ensure quality production, consisting of several lines, which include a sufficiently broad range of standards, guidance for the pharmaceutical and microelectronics industries, high-tech industrial production (food production, optical and packaging industry, medical and sensor technology, as well as micromachining industry).

 

By 2014 all the national pharmaceutical companies are obliged to go to the GMP standard that defines the parameters of each production stage, on the material from which made the floor in the shop, and the number of microorganisms in the air to special clothing to employees. Regulation of production in accordance with GMP standards requires a comprehensive approach to organizing all of the processes.

Rules of production of medicines are paying special attention to clean indoor air. The very first rules of GMP appeared in the 60s in the U.S., had already formed a favorable environment for the formation of rules of production.

First, the producers themselves have sought to provide high quality and competitiveness of their products. Second, when creating a GMP rules take into account the need to provide assurance on the part of consumers. At this stage, the U.S. has had a good experience in establishing quality management systems in aerospace and other industries, as well as the creation of clean rooms. The emergence of common standards in the production of pharmaceuticals in Russia has become urgent until much later. It can be assumed that the GMP standard - a set of the same Russian GOST and SNIP, but one of the main criteria for GMP standard is to create a "clean room".

Purity of room are formed by technology and organization of production. The drug should contain only what is included in its composition. Everything else can be attributed to contamination (particles, chemicals, microorganisms).

Clean rooms protect from pollution as a product itself, as well as the environment and equipment on which these products are produced. This is the basic requirement of GMP.

GMP standard provides:

  1. Using in production high quality raw materials.
  2. A special production process in which the product keeps its qualitative properties.
  3. Appropriate measures to ensure quality control during product production and the end of its shelf life.

For a successful transition to GMP standards should clearly understand the orientation of the enterprise. If the production of the product is aimed only at the national market should sufficient comply national regulations GMP. If the company is focused also on exports, should be based on international instruments, or adhere to the national requirements of importing countries.


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