FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

History

  
1973
The department of technology of endocrine drugs of the All-Soviet-Union Scientific Research Institute of Automation (VNIIA) and Moscow Drug Products Plant No. 1 served as the basis for creating the All-Soviet-Union Research and Development Institute of Blood Substitutes and Hormonal Drugs Technologies (VNIITKGP).
1974
In accordance with the order of the Ministry of Medical Industry dated March 18, 1974 № 107, the Scientific Council of VNIITKGP was established in order to consider the main issues of scientific activity, which is operating until nowadays.
1986
Due to the merger of the Ministry of Medical Industry and the Chief Directorate of Microbiological Industry under the USSR Council of Ministers, VNIITKGP was transferred to the Ministry of Medical and Microbiological Industry. The Institute was the leading research institution in the field of creation, study, development of technology and industrial production of blood substitutes, blood preservatives, hormonal and organotherapeutic medicines, their synthetic substitutes, suture surgical materials from animal raw materials, biologically active substances, as well as the base organization of the Ministry of Medical and microbiological industry standing for standardizing the above-mentioned groups of medicines.
1993
The VNIITKGP was renamed to become FSI «State Institute of Blood Substitutes and Medical Preparations» (FSI «SIBS & MP»). During the 1990s, which were the difficult time for the whole country, the Institute was the only one of the 7 specialized scientific institutions in the industry to preserve its structure and drugs development functions.
2000
The Federal State Institution «State Institute of Blood Substitutes and Medical Preparations» was transferred to the Ministry of Industry, Science and Technologies of the Russian Federation.
2005-2006
The main activity of the Institute was the implementation of applied scientific research in the field of medicine and pharmacology in the area of studying mechanisms of medicines’ action on the human body, studying and development of medicines and medical devices. Over the past 10 years, the Institute has created 38 drugs (blood substitutes, organotherapeutic drugs, genetically engineered insulins, and others), the majority of which have been introduced into production at the country’s largest pharmaceutical enterprises.
2008
FSI «State Institute of Blood Substitutes and Medical Preparations» was transferred to the Ministry of Industry and Trade of the Russian Federation.
2014
The Institute was renamed to become the Federal State Institution «State Institute of Drugs and Good Practices» (FSI «SID & GP»). FSI «SID & GP» was accredited as the expert organization engaged in the license control of pharmaceutical enterprises located in the Russian Federation, in the composition of the commission of the Minpromtorg of Russia.
2015
FSI «SID & GP» was authorized to inspect the manufacturers of human drugs effecting the manufacturing outside the Russian Federation to check the manufacturers’ compliance with the GMP Rules with the purpose of issuing the certificates of the drugs manufacturers’ compliance with Good Manufacturing Practice.
2016
Beginning of the inspection of the manufacturers of human drugs effecting the manufacturing outside the Russian Federation and supplying their products to the pharmaceutical market of Russia for compliance with Good Manufacturing Practice. The GMP I all-Russian conference with the participation of foreign specialists was carried out, bringing together the pharmaceutical industry experts and the representatives of the regulatory bodies and specialized associations.
2017
The Russian Ministry of Industry and Trade and the State Institute of Drugs and Good Practices (SID&GP) have jointly initiated the pre-application procedure for the Russian Inspectorate to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Its membership will allow peer-to-peer cooperation with inspectors from all over the world, sharing experience and fair discussion of inspections related issues with foreign colleagues. The Russian Ministry of Industry and Trade along with the SID&GP provided significant support for the opening of the independent ISPE branch in Eurasia. The goal here is to gain access to global trends and international expertise in pharmaceutical engineering for the pharmaceutical community of the Eurasian Economic Union. Publication of the monograph «What Is Good And What Is Bad In Pharmaceutical Production» by Vladislav Shestakov and Yuriy Podpruzhnikov. Director of the Institute was awarded the «Honorary Chemist» title and state awards of the Syrian Arab Republic, in recognition of SID&GP staff’s contribution to inspection of Syrian pharmaceutical plants. Winning the All-Russia open contest of pharmaceutical experts ‘Platinum Ounce’ in the nomination «For contribution to implementation of GMP-standards in Russia».
2018
The quality management system of FSI «SID & GP» is certified on compliance with the requirements of the international standard ISO 9001: 2015 and the national standard GOST R ISO 9001-2015. The Institute’ Director, Vladislav Shestakov, in the opinion of more than 500 pharmaceutical industry experts, was recognized as the most influential person in the development of GMP in Russian and international pharmaceutical sphere and won the “Influence Rating” award. FSI «SID & GP» held the III All-Russia GMP-Conference with international participation in Kazan. The Conference set a record for the number of guests and participants – more than 2,000 specialists from Russia and other countries. FSI «SID & GP» celebrated the anniversary date – the 45th anniversary of its founding.