GEROPHARM R&D Centre: First in Russia to Get the Status of Commercial GLP-Certified Laboratory

Pharmacology Laboratory at the GEROPHARM Research & Development Centre confirmed its compliance with the international standards of good laboratory practice by obtaining national GLP certification. Thus, the company’s R&D Centre has become the first commercial laboratory in Russia and the first centre to conduct in vitro studies (on cell lines) under the GLP standards.

The laboratory was inspected by experts of the Federal Accreditation Service of the Russian Federation (Rosakkreditatsia).

The GLP rules are used worldwide as a mandatory quality standard for non-clinical laboratory studies. They establish a single, rigorous system that ensures the objectivity and reproducibility of the data. It concerns all the processes in the organisation, including the procedure for conducting research, the equipment used, staff qualifications, reporting methods, etc.

The certified laboratory status is a guarantee that the studies of medicinal products are conducted with high quality standards and produce results of high accuracy as prescribed by the international good laboratory practice.

Currently, there are 12 GLP-certified centres in Russia; 8 of these are functional and listed as testing laboratories complying with the principles of good laboratory practice; 4 other laboratories’ GLP-compliant status is suspended. These organisations are state-controlled and conduct in vivo studies (in laboratory animals). The GEROPHARM Research & Development Centre became the 13^th GLP-certified centre in Russia.

Roman Dray, Director of Research & Development Centre, GEROPHARM, says,

“We were initially guided by GLP standards when forming the operations of the company’s R&D centre. In 2019, we made the first step towards a documented evidence of that fact: voluntary certification by the Russian Register, Association for Certification; now we are GLP-certified at the national level. It means a new level and the beginning of a long way towards accreditation by international regulatory authorities, in Europe. By doing that, we will improve our potential as exporter and make the way for GEROPHARM products to EU markets easier and faster.”