The Geropharm Research Center has become the first commercial laboratory in Russia and also the first center that conducts in vitro tests in accordance with GLP standards, the pharmaceutical manufacturer reports.
“The pharmacology laboratory of the Research Center has confirmed its compliance with international GLP standards by receiving national GLP accreditation. The inspection was carried out by experts of the Federal Service for Accreditation of the Russian Federation,” the report says.
At the moment, there are 12 centers in Russia that have received GLP accreditation, eight of them are functioning and are included in the register of testing laboratories that comply with the principles of good laboratory practice. Four more have their GLP compliance status temporarily suspended. These organizations are state-owned and conduct in vivo tests (on laboratory animals). The Geropharm Research Center has become the 13th accredited GLP center in Russia.
“When building the operations of the company’s research center, we were guided by the GLP standards from the very beginning. In 2019, the first step was taken in obtaining documentary confirmation of this: we passed the voluntary certification of the Russian Register Certification Association, and now we have received national GLP accreditation. This is a new phase and the beginning of a long way to accreditation with foreign, namely, European regulators. It will make a significant contribution to the company’s export potential development and will help Geropharm products to enter the EU markets sooner,” said Roman Dray, Director of Geropharm Research Center.
The GLP rules are used worldwide as a mandatory quality standard for preclinical laboratory tests. They establish a single, rigorous system that ensures the objectivity and reproducibility of the data. It concerns all the processes in the organization, including the procedure for conducting research, the equipment used, staff qualifications, reporting methods, and other aspects.