Introducing GMP Standards in the Russian Federation

      Today, there is no single GMP standard adopted throughout the world. Taking into account the fact that it is impossible for the majority of countries to achieve the full compliance with GMP standards, the World Health Organization (WHO) has developed a list of the most important GMP requirements that define the necessary minimum of standards. Russia had taken the EU GMP standard as a basis, and in 2004 it developed the first version of the Russian GMP standard that was prepared by the Association of Microcontamination Control Engineers (AMCCE). Based on this standard, in 2004 Decree of the State Standard of Russia No. 160-st, GOST R 52249-2004 “Rules for the Medicines’ Production and Quality Control” dated March 10, 2004 was approved that was harmonized with the EU GMP rules (Good Manufacturing Practice for medicinal products) (http://docs.cntd.ru/document/1200036160).
       It is necessary to note that at the first stage of introducing GMP, the national pharmaceutical industry suffered some losses as a result of the considerable financial expenses, but then funds for the production of medicines were saved. It was achieved due to strict mechanisms of control and surveillance at all stages of production (certification or validation of production processes at the enterprise), which allowed the medicine quality system to function adequately and to increase production volumes.
        The next stage of implementing GMP was the approval of order of the Ministry of Industry and Trade of Russia No. 916 “Rules of Good Manufacturing Practice” dated June 14, 2013 (http://docs.cntd.ru/document/499029882). Then  the  GMP  standards’ implementation   was   developed   by   the   approval   of    the   “Rules for    the   organization    and   conduct   of   inspection   of   medicines’ producers    for   compliance    with    the    rules    of    good manufacturing practice, as well as issuing conclusions on the medicine producer’s compliance with the set requirements” (http://minpromtorg.gov.ru/activities/services/licensing/1_11/1_11_3/).On May 6, 2017, the national medicines’ markets of five EEU states (Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia) united and began their work in a single space format in accordance with the “Rules of Good Manufacturing Practices of the Eurasian Economic Union” (http://docs.cntd.ru/document/456026099).

Resource:

http://www.jpsr.pharmainfo.in/Documents/Volumes/vol10Issue06/jpsr10061813.pdf