SOME ASPECTS OF CONDUCTING GMP INSPECTIONS IN RUSSIA

Abstract

Development of pharmaceutical industry in Russia requires for a common approach to the qualification and standardization of manufacturing process for drug products. To achieve this goal the package of relevant legal Acts was approved in Russia in 2015-2016, aimed at harmonizing the rules of Good Manufacturing Practices - GMP, in particular in the field of inspection.

Keywords

• gmp-инспекция
• gmp
• inspection
• eeu