On October 8 and 9, inspectors of the State Institute of Drugs and Good Practices together with their peers from Armenia and Kazakhstan took part in a mock GMP inspection at the Gideon Richter Chemical Plant in Budapest, Hungary. The mock GMP inspection is an integral part of the educational program of the Institute within the framework of the WHO Global Learning Opportunities project.
The inspection brought together representatives from three countries: the Department for Pharmaceutical Manufacture Inspections of the State Institute of Drugs and Good Practices (Russia), the Scientific Center for Drug and Medical Technology Expertise (Armenia), and the National Center for the Expertise of Medicinal Products, Devices and Equipment of the Kazakhstan Health Ministry.
The inspection pursued exchange of experience between the EAEU regulatory authorities during GMP inspections of pharmaceutical manufacturers. Additionally, such joint activities foster common principles of conducting inspections and help develop unified approaches towards classification of deviations.
«For the pharmaceutical community, joint mock GMP inspections are not only an opportunity to exchange practical knowledge, professional know-hows and to shape common standards and approaches towards inspection,» noted Vladislav Shestakov, director of the State Institute of Drugs and Good Practices. — It also means a new step on the path of the inter-regulatory dialogue regarding GMP inspection procedures between the EAEU member states.