World Journal of
Pharmaceutical and Life Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Life Sciences
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
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Abstract

RUSSIAN GMP INSPECTION. USER’S MANUAL

Gildeeva G. N., Belostotsky A. V. and Yurkov V. I.

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.

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