GMP and ISO

Production facilities of the plant was built and designed in accordance with international standards.

Project of production facilities was realized "from scratch" engineering of the Austrian company "M+W Group" in full accordance with the requirements of the European standards GMP and ISO. The production is equipped with high-tech equipment of the European producers (MediSeal, MG2, KORSCH, BOSCH, Muller), that allows to provide stable high quality of the final product. One of the requirements in the procurement of new equipment was the presence of the documents confirming compliance with the requirements of GMP and ISO quality certificate and certificate for materials in contact with drugs. All the equipment is qualified, which is part of the quality assurance system.

To ensure the continuous monitoring of the production process and the quality of drugs produced the factory is implemented and constantly improved quality management system (QMS). System quality management our company is built in accordance with the requirements of Russian and European standards in this area (GOST R 52249–2009 "Rules of production and quality control of medicines", EU GMP guide ICH Q10 and standard GOST R ISO 9001-2011 "quality management System. Requirements"), that is confirmed by the license of the Ministry of industry and trade of the Russian Federation and the ISO Regional center quality control.

To assess performance finding ways of development and improvement of the quality system at the company has implemented a system of regular internal audits (sevenspace) all units at least 1 time in year. In the system of education quality standards and GMP and ISO included employees of all levels.

Production facilities of the plant was built and designed in accordance with international standards.