History of GMP-standards

World history of GMP standards originates from 1963 in the U.S., where a group of scientists have developed special rules to regulate the conditions of quality and safe production of medicines - standard Good Manufacturing Practice (GMP).

GMP FDA standards supplemented in 1965, 1971, 1978, 1987, 1992, and the first international document on GMP, appeared in 1968, established by WHO, a little later - in 1969 a resolution was adopted by WHO, which prescribes the rules to apply GMP WHO all countries. Starting from 70s of last century, GMP became widespread throughout the world, with the exception of the USSR Ministry of Health of the Soviet Union declared its uninterested in the implementation of such rulesand the issue of transition to GMP, the enterprises of the Soviet Medical and Microbiological Industry, has been postponed until in 1991. It was only after the collapse of the Soviet Union, the CIS countries themselves have begun to transition to standard GMP.

In 1991 appeared rules of the European Union's GMP (GMP EU), approved by the directive 356/91. In 2003, this directive was amended by directive 2003/94.

In Russia in 2001 was adopted standard closer to the rules of GMP. Only in 2004 was put into effect GOST R 52249-2004, which is corresponded to the rules of the EU GMP. After that, in January 1, 2005 compliance with the rules of GMP in pharmaceutical production in the Russian Federation is required.

In Ukraine, in 1997, were approved guidelines MV 64U-1-97, which attempted to combine in one document the rules of GMP EU and GMP WHO, as a result - as a absence of harmony with one or the other. In this regard, in 1998 introduced a normative document MLA 01.001-98, based on the rules of GMP WHO (GMP WHO), while the government adopted a strategy to integrate all legislation with the European Union. It was only in 2001 approved the Manual 1.1.42 "Drugs. Good Manufacturing Practices", which fully complies with GMP rules of the European Union.