PDA Letter Article

Russian GMP Inspections Present Challenges, Opportunities: Part II

by Vladislav Shestakov, Russian State Institute of Drugs and Good Practices, and Elizabeth Meyers, Amgen


Harmonization in the field of GMP inspections within the EAEU

[Editor's Note: Read Part I for background on Russian GMP inspections.]

A substantial part of activities by the Russian GMP inspectorate involves integrating Russia into the global pharmaceutical community, participating in development of a regulatory framework for the common pharmaceutical market among Eurasian Economic Union (EAEU) member countries, and creating an international independent expert board of inspectorates. The latter is the most promising, as this project suggests establishment of trust in the inspectorate along with increased numbers of inspections and mutual GMP recognition to decrease the burden on pharmaceutical manufacturers, all of which substantially improve the quality of production.