PDA Letter Article

Russian GMP Inspections Present Challenges, Opportunities: Part I

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

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What to Expect from a Russian GMP Inspection

[Editor’s Note: Part II of this article addresses the ongoing harmonization activities in the field of GMP inspections within the Euroasian Economic Union (EAEU).]

Over the past two years, many international companies have hosted Russian inspectors at their manufacturing sites (1). Below is information describing the general regulatory landscape in Russia, history of the Russian GMP inspectorate and common observations made by Russian inspectors. This can help companies prepare for Russian inspections, anticipate the types of findings that may be delivered and understand how to address these findings.