FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

FSI “SID & GP” of the Russian Ministry of Industry and Trade shared its perspectives on conducting GMP inspections in the conditions of aseptic process with the Institute for Medicines and Medical Devices of Montenegro during an educational webinar

On July 26, 2021, FSI “SID & GP” of the Russian Ministry of Industry and Trade and Institute for Medicines and Medical Devices of Montenegro conducted their first educational webinar.
The webinar was organized for inspectors of Montenegro with a view of transferring the experience of FSI “SID & GP” of conducting GMP inspections of foreign manufacturing sites.   

 

Natalia Popova, head of section for drug manufacturing inspections of FSI “SID & GP” of the Russian Ministry of Industry and Trade, delivered the presentation entitled “Aseptic Process Simulation (APS). Basic Requirements” at the webinar.

 “Holding such joint educational events is of considerable importance for the both organisations, as it contributes to an exchange of best practices and knowledge, and allows to discuss pressing issues   related to  inspecting manufacturing sites for compliance with the requirements of Good Manufacturing Practice rules, – noted in her welcoming remarks Natalia Popova. – And taking into account the current outbreak of the COVID-19, caused by a novel coronavirus, such seminars in an online format are becoming especially valuable”.

From the Institute for Medicines and Medical Devices of Montenegro three employees of the inspectorate, in their listener capacity, attended the webinar: head of the inspectorate Sonja Bulajić, GMP inspector Uroš Labudović and a trainee inspector Miloš Luburić.

“Our inspectorate was established in the end of 2020 in accordance with the new drug legislation, and it is within our competence to conduct inspections for compliance with the requirements of the following good practices: GMP, GDP, GPvP and GCP. However, due to the COVID-19 pandemic we have been unable to conduct inspections as of yet, but we do anticipate that very soon we would be able to implement our authority in practice”, — clarified head of the inspectorate of the Institute for Medicines and Medical Devices of Montenegro Sonja Bulajić before the start of the webinar.

The relevance of the webinar’s topic is that on the territory of Montenegro there are two drug manufacturers: one specializes on medical gases, and the other on sterile liquid dosage forms, in the manufacturing of which an aseptic filling is used.

On 23 April, 2021, FSI “SID & GP” of the Russian Ministry of Industry and Trade and Institute for Medicines and Medical Devices of Montenegro signed a Cooperation agreement. In February 2021 Institute for Medicines and Medical Devices of Montenegro has approved the import of Russia’s vaccine against COVID-19 “Sputnik V”.