What is 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
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.
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.
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
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:
- Using in production high
quality raw materials.
special production process in which the product keeps its
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
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.