FSI «State Institute of Drugs and Good Practices» (FSI «SID & GP») is the subordinate institution of the Ministry of Industry and Trade of the Russian Federation, which is authorized to conduct inspections of manufacturers of medicines for human use, whose production is located outside the territory of the Russian Federation, on compliance with GMP requirements in order to issue certificates on compliance of medicines’ manufacturers with the requirements of Good Manufacturing Practice.
The Institute was founded in 1973 as the All-Union Scientific Research Institute of Blood Substitutes and Hormonal Products Technology and is still a major research center in the field of R&D.
Besides inspecting production sites on GMP compliance and developing new dosage forms, «SID & GP» carries out the following activities:
- Engineering practices and cleanroom qualifications
- Monitoring industry markets and government programs
- Organizational and analytical support and monitoring of the implementation of the state program of the Russian Federation «Development of the pharmaceutical and medical industry»
- Collection and analysis of data on the production of medicines and medical devices in the Russian Federation, analysis of the product portfolio of Russian and foreign enterprises
- Collection and processing of data for the formation of information bases on design tasks
- Monitoring the transition of medicines manufacturers to medicines labeling with identification tools using cryptographic protection
- The structure of «SID & GP» includes a medical center.
- At the end of 2017, a «Joint program to promote the implementation of Good Practices in the Russian pharmaceutical industry» was developed and launched in order to intensify the work on the analysis of inspection experience and develop the relevant competencies of the Inspectorate, to solve case situations associated with the application of GMP standards, and to prepare thematic modules and training cases, as well as organization of further effective translation of the results of this work into Russian enterprises.
- The Inspectorate of «SID & GP» conducts regular work in the field of establishing cooperation with regulators of other countries.