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
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.