July 30, 2019
July 15-19 OECD experts performed a comprehensive audit of the Russian Good Laboratory Practice system in terms of its compliance with organization’s standards. The evaluation included the analysis of Russian legislation, documentation and procedures used, the work of RusAccreditation being the national monitoring body in Russia, and also the assessment of inspectors’ work during the full inspection of the Russian testing center.
Preliminary results of the Russian GLP system audit were announced by experts July 19 at the meeting with the Head of RusAccreditation Alexey Khersontsev and representatives of the Ministry of Economic Development of the Russian Federation. According to international experts the Russian system complies with the requirements of OECD documents. The work of Russian inspectors examining the testing center seeking to be included in the register of Russian testing laboratories (centers) that comply with the GLP principles was also given a high rating. A detailed report from OECD experts will be presented in autumn of 2019. The audit was conducted as part of the Russia-OECD “Technical assistance in developing the Russian GLP system” project which started September 3, 2018.
Within the framework of the project’s events held in 2018-2019 Russian GLP inspectors participated as observers in inspections that were performed abroad by the inspectors of Britain’s and Finland’s monitoring bodies. Training sessions for representatives of testing centers, Russian GLP inspectors and regulatory organs also took place.
There are 11 laboratories operating within the Russian GLP system, most of which conduct research in the sphere of medications, chemicals and pesticides.
In Russia 15 main regulatory documents are approved as regards Good Laboratory Practice and 104 GOSTs on test methods which are translations of the relevant OECD documents. More information on the GLP system in Russian can be found on the website.