REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot126510.21518/1561-5936-2018-6-46-49Original ArticleThe main deficiencies identified during GMP-inspections by the russian inspectorateGildeevaG. N.noemail@neicon.ruPodpruzhnikovYu. V.noemail@neicon.ruShestakovV. N.noemail@neicon.ruSechenov First Moscow State Medical UniversityNational Pharmaceutical UniversityState Institute of Drugs and Good Practices061220186464918032022Copyright © 2018,2018The Ministry of Industry and Trade of the Russian Federation has been carrying out inspections of the foreign pharmaceutical manufacturers since April 2016. The inspectorate checks the foreign manufacturer's compliance with the Russian standards of Good Manufacturing Practice (GMP). Inspection is a key element in assessing the compliance of pharmaceutical manufacturers with GMP requirements. Nearly all the inspections identify discrepancies or violations that are documented in the inspection report and serve as a basis for taking regulatory actions such as the decision to issue a GMP-certificate or refuse to issue it, an order to eliminate discrepancies /violations, suspend or cancel a license, a marketing authorization, prohibition of manufacture, etc.GMP-inspectionGMP инспекцияЕАЭСЕАEU1.EMA/572454/2014 Rev.17. GMP Inspection Report - Union Format. P.175-178. http:// www.ema.europa.eu/.2.PI 013-3. Standard operating procedure PIC/S Inspection Report format. Annex. 1. PIC/S 25 September 2007. http://picscheme. org/.3.Guidance on Good Manufacturing Practices: inspection report. WHO Technical Report Series, No 996, 2016 Annex 4. http://who.int.4.Правила проведения фармацевтических инспекций. Официальный веб-сайт Евразийской экономической комиссии. http://eurasiancommission.org.5.Приказ Минпромторга России от 04.02.2016 №261 «Об утверждении форм заявления о выдаче заключения о соответствии производителя (иностранного производителя) лекарственных средств для медицинского применения требованиям6.Шестаков В.Н., Подпружников Ю.В. Что такое хорошо и что такое плохо в фармацевтическом производстве. М., 2017. 180 c7.URL: http://minpromtorg.gov.ru/ docs/#!reestr_zaklyucheniy_gmp.8.URL: http://pharmacopoeia.ru/klassifikatsiya-zamechanij-pri-provedenii-rossijskoj-gmp-inspektsii/.