The system of secondary reference standards in drug quality control laboratories

Ведомости Научного центра экспертизы средств медицинского применения

卷:0

D. A. Leontiev¹ 

[1]Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines

关键词: стандартные образцы;    анализ лекарственных средств;    система вторичных стандартных образцов предприятия;    reference standards;    quality control of medicines;    the system of secondary reference standards of a facility;   

DOI  :  

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown