State Institute of Drugs and Good Practices
In 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).
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.
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.
The Institute is actively cooperating with pharmaceutical enterprises and drugs development companies. During the last 10 years, the Institute created 38 drug products (blood substitutes, organotherapeutical preparations, genetically engineered insulins, etc.), the majority of which were put into manufacturing at the major pharmaceutical enterprises of the country.
FSI “State Institute of Blood Substitutes and Medical Preparations” was transferred to the Ministry of Industry and Trade of the Russian Federation.
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.
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.
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.
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».See more