RUSSIAN GMP INSPECTION. USER’S MANUAL
Journal Title: World Journal of Pharmaceutical and life sciences - Year 2017, Vol 3, Issue 6
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. How to obtain RU GMP certificate? What is the role and responsibilities of Regulator? What is the role and responsibilities of drug Manufacturer? What to do if the Manufacturer has received the refusal of RU GMP certificate? This article answers these and other questions.
Authors and Affiliations
Gildeeva G. N.
Keywords
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