SID & GP – being ahead of time
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 Mr. Vladislav Shestakov.
Talking about the key results of the year gone by, Mr. Vladislav 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. Today, the name of FSI «SID & GP» has become associated with the seal of excellence in manufacture of drug products. Over a period of three years (from 2016 to 2018), 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.
«The Russian inspectorate was one of the first in the world to implement the practice of involving colleagues from other inspectorates as observers», said the Director of FSI «SID & GP» of Minpromtorg of Russia Mr. Vladislav Shestakov.
In its activities, the State Institute applies high technologies and the most advanced methods. Journalists were presented the following: a tool for creation of the common data environment within the Institute – «Digital Inspectorate», the automated information system «MedPharmUchet», the automated information system «Inspectorate», the Virtual Plant initiative. These projects were demonstrated in detail by Ms. Nataliya Chadova, the Head of Drug Manufacture Inspections and Expert Evaluation Directorate, Ms. Madina Sottaeva, the Head of EAEU Pharmaceutical Inspectorates Cooperation Organization Department, Mr. Igor Falkovskiy, the Head of Good Engineering Practice Department. State-of-the-art technologies in the work performed by the Inspectorate are not simply a fashion craze – it is a vital element of the more precise work and the more in-depth analysis of additional information.
Today, FSI «SID & GP» of Minpromtorg of Russia 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.
The work of the Inspectorate contributes to providing Russian patients with high-quality drugs.
Mr. Vladislavl Shestakov, Ms. Nataliya Chadova, Ms. Madina Sottaeva, Mr. Igor Falkovskiy responded to the questions asked by journalists and editors of industry, regional, and federal publications.
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed