Changes in Russian legislation since 2016 allow to register new products in Russia only to foreign pharmaceutical companies with a GMP certificate which meets Russian state requirements, while, since 2017, this certificate is mandatory also for submitting changes on a regulatory documentation for products already on the market. Quality director of JSC Grindeks, Dr.chem. Juris Hmeļņickis says: “Grindeks has been complying with GMP requirements since 2003 when we received European Union GMP certificate. Receiving Russian certificate, where the requirements have harmonised with global practice, is another acknowledgement that during these years Grindeks quality system has been continuously maintained at the level of highest global quality standards.”
A compliance with GMP requirements of Grindeks’ drug manufacturing, quality assurance and control was examined by Russian inspectors of The State Institute of Drugs and Good Practices (Государственный институт лекарственных средств и надлежащих практик), who evaluated Grindeks quality system, facilities, documentation and information received from responsible personnel during inspection. After Grindeks’ inspection report was evaluated by The Ministry of Industry and Trade of Russia (Министерство промышленности и торговли Российской Федерации) it issued a GMP certificate to the company. “Inspection at the company was performed by highly competent professionals, strengthening our belief that only pharmaceutical products of the highest quality can reach patients in Russia,” J. Hmeļņickis noted.
GMP certificate is valid for 3 years since issuing. Before JSC Grindeks, Russian GMP was already issued to Groups’ subsidiaries JSC Tallinn Pharmaceutical Plant (Estonia), HBM Pharma (Slovakia) and JSC Kalceks (Latvia), which now confirms compliance with the high GMP quality system of the whole Grindeks Group.