ANALYSIS OF THE APPLICATION OF FOREIGN QUALITY MANAGEMENT EXPERIENCE IN PHARMACEUTICAL ENTERPRISES OF UKRAINE

Abstract

The paper presents an analysis of the integration of foreign quality management practices within international pharmaceutical enterprises, emphasizing the significance of international standards such as GMP, EMA guidelines, and the principles of Kaizen and TQM. The study explores how these global frameworks can enhance production quality, safety, and compliance in Ukrainian pharmaceutical sector. By comparing quality management systems from the USA, the EU, and Japan, the research identifies key best practices for improving operational efficiency, quality consistency, and regulatory alignment in Ukraine. The study aims to analyze the foreign experience of quality management at pharmaceutical enterprises of the USA, the EU, Japan, and other developed countries in order to determine the best practices and the possibilities of their integration into the Ukrainian standards of the pharmaceutical industry. Materials and methods. The study includes an analysis of the activities of 13 pharmaceutical enterprises (3 each from the USA, the EU, and 4 from Japan), as well as 3 Ukrainian companies that have already integrate certain elements of foreign quality management experience. In order to achieve the goal of the research, the following methods were used: analysis of normative documents; comparative analysis; case study. Results. The integration of global quality management practices can significantly improve product quality at Ukrainian pharmaceutical enterprises, strengthening their position on the international market. The implementation of such approaches requires investments in the modernization of production facilities, training of personnel and improvement of internal procedures, but in the long term these measures will provide Ukrainian pharmaceutical enterprises with a higher level of product quality, production efficiency and reputation in the global market.