The results of the work by the GMP-inspectorate became the main topic of the meeting with representatives of the top Russian mass media held by the Director of the State Institute of Drugs and Good Practices of Minpromtorg of Russia (FSI ‘SID&GP’), Vladislav Shestakov.
Talking about the key results of the year gone by, Mr. Shestakov emphasized that from 1973 (over a period of 45 years), the State Institute developed 200 new quality control methods for drugs and production processes and 26 novel drug products, elaborated 900 scientific papers, issued 78 authorship certificates and patents. Over a period of three years, 1376 inspection were carried out, with 667 of them in 2018. Since 2013, the staff of the Institute has increased from 18 to 329 professionals.
The Ministry of Industry and Trade of the Russian Federation empowered ‘SID & GP’ with the leading function of supervising and inspecting drug manufacturing sites abroad. The first country visited by the Russian inspectorate was Slovenia. Now, the schedule of inspections for 2019 is already available, with inspections to be carried out in Spain, Palestine, Chile. The State Institute eagerly cooperates with inspectorates from other countries.
Vladislav Shestakov, the Director of FSI ‘SID & GP’, stated:
“The Russian inspectorate was one of the first in the world to implement the practice of involving colleagues from other inspectorates as observers.”
In its activities, the State Institute applies high technologies and the most advanced methods. During the press-conference FSI ‘SID & GP’ leaders presented a tool for creation of the common data environment within the Institute called “Digital Inspectorate”, the automated information system “MedPharmUchet”, the automated information system “Inspectorate” and the Virtual Plant initiative.
Today, FSI ‘SID & GP’ is the Russian competence center for good practices striving for maintaining its scientific potential on the highest level possible. Over the years, the State Institute has become the fundamental structure in the system of pharmaceutical industry, the base of healthcare and drug safety.