JSC Grindeks has received Russian Good Manufacturing Practice (GMP) certificate to confirm the quality system of Grindeks complies with the current legislative requirements in one of the company\u2019s key markets.<\/p>\n\n\n\n
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 Hme\u013c\u0146ickis says: \u201cGrindeks 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.\u201d<\/p>\n\n\n\n
A compliance with GMP requirements of Grindeks\u2019 drug manufacturing, quality assurance and control was examined by Russian inspectors of The State Institute of Drugs and Good Practices (\u0413\u043e\u0441\u0443\u0434\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0439 \u0438\u043d\u0441\u0442\u0438\u0442\u0443\u0442 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u0438 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0438\u0445 \u043f\u0440\u0430\u043a\u0442\u0438\u043a)<\/em>, who evaluated Grindeks quality system, facilities, documentation and information received from responsible personnel during inspection. After Grindeks\u2019 inspection report was evaluated by The Ministry of Industry and Trade of Russia (\u041c\u0438\u043d\u0438\u0441\u0442\u0435\u0440\u0441\u0442\u0432\u043e \u043f\u0440\u043e\u043c\u044b\u0448\u043b\u0435\u043d\u043d\u043e\u0441\u0442\u0438 \u0438 \u0442\u043e\u0440\u0433\u043e\u0432\u043b\u0438 \u0420\u043e\u0441\u0441\u0438\u0439\u0441\u043a\u043e\u0439 \u0424\u0435\u0434\u0435\u0440\u0430\u0446\u0438\u0438)<\/em> it issued a GMP certificate to the company. \u201cInspection 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,\u201d J. Hme\u013c\u0146ickis noted.<\/p>\n\n\n\n GMP certificate is valid for 3 years since issuing. Before JSC Grindeks, Russian GMP was already issued to Groups\u2019 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.<\/p>\n","protected":false},"excerpt":{"rendered":" JSC Grindeks has received Russian Good Manufacturing Practice (GMP) certificate to confirm the quality system of Grindeks complies with the current legislative requirements in one…<\/p>\n","protected":false},"author":3,"featured_media":2021,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2020","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/posts\/2020","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/comments?post=2020"}],"version-history":[{"count":0,"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/posts\/2020\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/media\/2021"}],"wp:attachment":[{"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/media?parent=2020"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/categories?post=2020"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/grindeks.com\/en\/wp-json\/wp\/v2\/tags?post=2020"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}