Representatives of FSI «State Institute of Drugs and Good Practices» took part in the GEP-Russia International Conference in Moscow
On October 16, representatives of FSI «State Institute of Drugs and Good Practices» took part in the GEP-Russia International Conference in Moscow. The сconference is intended to consolidate engineers from the pharmaceutical industry, and its main topic is New Trends in Pharmaceutical Engineering. Representatives of FSI «SID & GP» presented the reports regarding the issues of international collaboration in the field of pharmaceutical engineering.
In his greeting speech towards the сconference participants, Vladislav Shestakov, the Director of FSI «SID & GP», highlighted special importance of pharmaceutical engineering for Russia and the support of any significant initiatives related to development of this area by the Institute.
Vladislav Shestakov, the Director of FSI «SID & GP», noted in his opening speech: “As a State Institute, we have been successfully implementing GEP-related projects during the entire life cycle of a medicinal product, including design qualification, concept solutions development, technical audits of operating facilities, validation of computerized systems, and other projects. As of today, rapid development of the pharmaceutical industry forces companies to bring their manufacturing facilities to compliance with the modern practices and standards all over the world.”
In 2017, FSI «SID & GP» supported the initiative of creating a local ISPE branch in the EAEU territory that is currently the world’s largest non-commercial organization that brings professionals of the pharmaceutical industry together.
The GEP-Russia Conference saw speeches of Zdenek Pavelek, Quality Director of FAVEA Group, that is one of the founders of the Eurasian branch of ISPE, and Vladimir Orlov, Line Manager of the EAEU Pharma Inspectorates Coordination Unit of FSI «SID & GP», a member of the Eurasian branch of ISPE. In their reports they spoke about the history of ISPE establishment, the key tasks and goals of the global association and its local branches.
«The major task of ISPE is to promote the most topical and needed technologies and ideas for pharmaceutical production based upon up-to-date aspects of regulatory requirements, technical solutions and scientific knowledge as applied to the entire life cycle of a drug product,» Vladimir Orlov, a representative of the Eurasian Branch of ISPE, clarified. «To us, of utmost importance is involvement the pharmaceutical industry professionals from EAEU member countries to the process – this is the very reason why FSI «SID & GP» supports the process of creation of the local ISPE branch in EAEU at all levels.»
Sergey Orlov, an SME from the GEP unit of FSI «SID & GP», presented a report of the up-to-date requirements for labeling, serialization and aggregation systems, and representatives of other companies presented their pharmaceutical engineering cases with solution examples.
- The volume of Indian drugs in the Russian market was $770 mln in 2018
- Mr. Vladislav Shestakov called for taking a quantum leap in GLP
- Interaction points were discussed by SID & GP with EDQM
- The inspection of the foreign pharmaceutical company registering its drug product in Kazakhstan was carried out by the Russian Inspectorate
- 157 license holders out of 189 manufacturing sites have received a GMP-certificate following the procedure of filing an application