MODERN DEFINITIONS OF DRUG STANDARDIZATION

Abstract

The drug should always meet the needs of patients during diagnosis, treatment or prevention of diseases. Therefore, the quality of the medicinal product (the totality of its properties) is the most important characteristic and must meet the requirements established by the legislation of Ukraine, the World Health Organization (WHO) and the set of good practices GMP, GLP, GCP, GDP, GPP, GSP. Introduction to the terminology and assimilation of modern definitions of the standardization of medicinal products (StMP), the structure and basic principles of standardization in the pharmaceutical industry in accordance with the requirements of international quality standards of drugs and the Law of Ukraine “On Standardization”, the principles of creation and requirements for documentation for medicinal products for the purpose of obtaining competitive quality medicines are necessary. Standardization of pharmaceutical products creates an effective mechanism for controlling and managing the quality of pharmaceutical products. Therefore, the introduction into the terminology and assimilation of modern definitions of StMP, including, during the study of the educational discipline “Standardization of medicinal products” by future pharmacists, is extremely relevant in the modern educational environment. We considered the modern definitions of StMP, revealed and analyzed the peculiarities of teaching the educational discipline “Standardization of medicinal products” for students of higher education of higher educational institutions of the pharmaceutical profile of Ukraine, focused attention on the importance of understanding the main modern definitions of StMP in order to successfully implement the professional competencies of future pharmacists. After mastering the main modern definitions of StMP, there is a qualitative increase in the theoretical level and professional competencies of future pharmacists, their ability to navigate in modern approaches to improved standardized methods of pharmaceutical analysis and competitiveness in the pharmaceutical labor market increases.