According to Vladimir Orlov, Deputy Head of the Educational Center for Good Practices, State Institute of Drugs and Good Practices (SID & GP), a federal budgetary institution, the inspections and checks conducted in major foreign pharmaceutical companies have a great importance for the development of Russian drug manufacturing industry.
“Over the past year, SID & GP conducted 545 inspections in Russia and abroad involving more than 60 inspectors of various specialization,” he said. “In a number of cases, we observed a much more developed technological base on production facilities located in foreign countries. This is a tremendous experience for us, which can provide real assistance in the renewal of Russian technological base in the coming years. On the other hand, in some countries, we have seen substantial and even critical shortcomings, violations, and underdevelopment of manufacturing and control system. I am pleased to note that, in this regard, many major Russian companies largely outperform their foreign counterparts.”
Sergey Tsyb, Deputy Minister of Industry and Trade of Russia, agreed with the expert. He said that, in recent years, the development of Russian inspectorate system allowed many Russian companies to make a significant breakthrough by adopting the best practices of Western manufacturers ranging from technologies to manufacture and store medicinal products to the establishment of strict control system over the manufacturing. According to the Deputy Minister, 111 refusals were issued to foreign manufacturers in 2017 due to serious violations and non-compliance with the requirements of federal laws and regulations.