On October 1, a master class titled New Formats of GMP Inspection is to take place within the V All-Russian GMP Conference.
The block Practice. New Formats of GMP Inspection: Pass an Inspection Together with an Inspector is supported by the conference partner Novo Nordisk Company.
Novo Nordisk is a global pharmaceutical company operating in 80 countries and supplying products to more than 170 countries. It specializes in innovations in sphere of diabetes treatment, as well as treatment of severe chronic diseases: obesity, rare blood and endocrine system conditions.
The Russian production of Novo Nordisk is based in Kaluga. The project of this insulin-producing facility built “from scratch” was discussed at the highest possible level with involvement of the RF Government. In 2015, the company launched its production facilities providing Russian insulin-dependent patients with modern drugs and medical devices.
Since 2018, Novo Nordisk has been operating this high-tech facility on the end-to-end production basis. Here, the company produces a full range of modern insulin medications that have no analogues in Russia. The production complies with the national and international GMP standards, as well as high ethical and sustainability principles. A successful localisation of unique manufacturing in conformity with good practices is a useful experience in the Russian market. It is of interest for the professional community and can serve as an example for future developing companies.
Irina Krasnokutskaya, Regulatory Affairs Manager at Novo Nordisk LLC, will make a presentation within the master class New Formats of GMP Inspection: Pass an Inspection Together with an Inspector. The discussion agenda will include the issue of online inspections that have become common practice during the COVID-19 pandemic; the participants will also analyse cases most frequently occurring during these past months. Irina Krasnokutskaya will comment on the practice of remote GMP inspections from the point of view of the manufacturer.
Natalia Chadova, Head of the Administration for Inspection of Pharmaceutical Production and Expertise of the State Institute of Drugs and Good Practice, Minpromtorg of Russia, will moderate the session. Also, Vladimir Smirnov, Chief Specialist of the Inspection of Pharmaceutical Production Department, State Institute of Drugs and Good Practice, was invited to speak at the event.
Conference participants will have an opportunity to put their questions to the speakers using a special application. They will also be able to communicate among themselves. Please find the detailed conference program at: https://old.gosgmp.ru/programma-konferentsii/