EAEU prepared the first package of standards for quality control of drugs

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In H1 2017, the Pharmacopoeia Committee of the Eurasian Economic Union, one of the key authorities of the Union’s common drug market, reviewed 120 drafts of general pharmacopoeia monographs prepared by the EAEU member states. 40 of them, elaborated by Belarus and Kazakhstan, were approved during the meetings of the Pharmacopoeia Committee and submitted for public discussion. These are standards designed to ensure the safe use of drugs by the patients, efficient operations of manufacturers and state control authorities. They will allow to establish conditions for the free movement of pharmaceutical products within EAEU and the exports to third countries.

The drafts approved so far by EAEU Pharmacopoeia Committee include such monographs of the Union Pharmacopoeia as the “Equipment,” “Physical and Physicochemical Methods,” “Tests for the Limits of Impurities,” and “Methods of Quantitative Determination.” The first monographs to pass the public discussions were “Viscosity” and “Melting Point – Open Capillary Method.” Other draft monographs approved by the Pharmacopoeia Committee and currently submitted for public discussions include “Stactometers,” “Ultraviolet Radiation Light Lamps for Analytical Purposes,” “Test Tubes for Comparative Tests,” “Degree of Coloration of Liquids,” “Relative Density,” “Refractive Index,” and other. These monographs define the requirements for laboratory equipment and methods used to control the quality of drugs in the EAEU.

SOURCE: gmpnews.ru
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