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GEROPHARM Group successfully passed Russian GMP audit

20 April 2015

GEROPHARM Group as a manufacturer of drug products for medical use, received a certificate of conformity to the requirements of Good Manufacturing Practice and quality control of drug products under Rule No 916 issued by the Ministry of Industry and Trade of the Russian Federation in June 14, 2013.

These Conclusions were issued for compliance of production organisation and quality control of drug products and pharmaceutical substances. Information about this Conclusion is placed on the official website of the Ministry of Industry and Trade of the Russian Federation.

A pharmaceutical quality system is implemented at the facility of GEROPHARM-Bio. This system is based on two standards: Good Manufacturing Practice (GMP), which includes the work organization, quality control and risk analysis, and ISO 9001 Quality Management System. In 2014 the company successfully passed the audit of the State Service of Ukraine and received a certificate of conformity to GMP production requirements (PIC / S GMP).

“We are not just talking about the implementation of GMP, but about the creation of Pharmaceutical Quality System, which is based on two standards: GMP and ISO,” said Natalia Novichkova. “We have managed to create a quality assurance system and a team that is motivated, engaged and, most importantly, has a new way of thinking which allows us to talk about a whole new approach to this important issue. Quality is not only the foundation on our work, but also the philosophy of every employee,” said Natalia Novichkova, Quality Director of GEROPHARM, Group of Companies.

Key aspect is a strategic independence of production from foreign raw materials suppliers. Finished dosage form and substance both are manufactured at the facility. According to three independent certified European laboratories (Proteome Factory AG Berlin, Prolytic GmbH Frankfurt am Main and Labor L + S AG) the substance conforms to the requirements of British and American Pharmacopoeia.

GEROPHARM Group is a dynamically growing company that develops and produces high quality drug products for the Russian market. The company invests in technological development and creation of innovative pharmaceutical infrastructure.

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