vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-15Research ArticleСТАНДАРТИЗАЦИЯ И КОНТРОЛЬ КАЧЕСТВА ЛЕКАРСТВЕННЫХ СРЕДСТВSTANDARDIZATION AND QUALITY CONTROL OF MEDICINESСистема вторичных стандартных образцов в лабораториях контроля качества лекарственных средствThe system of secondary reference standards in drug quality control laboratoriesЛеонтьевД. А.LeontievD. A.noemail@neicon.ruУкраинский научный фармакопейный центр качества лекарственных средствРоссияUkrainian Scientific Pharmacopoeial Center for Quality of MedicinesRussian Federation201613022018015055Copyright © Леонтьев Д.А., 20182018Леонтьев Д.А.Leontiev D.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/15

Проведен анализ систем фармацевтических стандартных образцов. Показаны недостатки одноуровневой системы. Для принятия надежного заключения о качестве лекарственных средств необходимо использование двухуровневой системы, важной частью которой является система вторичных стандартных образцов предприятия. Рассматривается опыт разработки и внедрения системы вторичных стандартных образцов в Украине в рамках перехода к двухуровневой системе.

Pharmaceutical reference standards systems have been analyzed. The imperfections of a one-level system have been demonstrated. It has been shown that for making a reliable decision on the quality of medicines one needs to use a two-level system, an important part of which is the system of secondary reference standards (SRS) of a facility. The article describes the experience in the development and implementation of the SRS system in Ukraine within the transition to a two-level system.

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The authors declare that there are no conflicts of interest present.