INTERNATIONAL EXPERIENCE IS IN THE ADMINISTRATIVE-LEGAL PROVIDING OF CONTROL SYSTEM BY QUALITY OF MEDICINAL FACILITIES IN THE FIELD OF PHARMACEUTICAL

Abstract

The drug quality assurance management system is a complex process of both objective nature – medicines must meet the requirements established by law, and subjective nature – they must meet the needs of consumers. At the present stage of development of Ukrainian society in critically difficult conditions – martial law, the system of quality management of medicines in the pharmaceutical sector, which is directly related to healthcare, is of strategic importance, because the health and quality of life of citizens is the most valuable asset of any country. Quality assurance in the provision of medical care in most countries is considered as the basis of national policy, including in Ukraine, where quality management systems in certain sectors have been developed and implemented for a long time, in particular, by various profiles by pharmaceutical market participants, as well as by some medical institutions. The process of managerial and legal regulation of the quality management system of medicines in the pharmaceutical sector requires continuous improvement during the implementation of procedural stages: planning, activity, development, inspection, improvement, which allows avoiding errors, losses or deterioration in the quality of products/preparations. The introduction of international standards in the process of quality management of medicines allows the pharmaceutical market in Ukraine to be trendy and competitive, taking into account modern trends in this area. It was established that the quality assurance management system for medicines covers both objective requirements defined by current legislation and subjective expectations of consumers regarding the satisfaction of their needs for high-quality and safe products. In the context of modern conditions of development of Ukraine, which are complicated by the effects of martial law, ensuring the effectiveness of the functioning of the pharmaceutical sector is of strategic importance, which directly affects the health of the population and the system of economic stability of the state. Stability and integration of quality standards into pharmaceutical production create the basis for the competitiveness of the Ukrainian market of medicines. The study focuses on the importance of improving the administrative and legal regulation of the quality of medicines. This includes the development of mechanisms for constant control, compliance with standards of good manufacturing and distribution practice (GMP and GDP), as well as the introduction of innovations aimed at reducing the risks of product quality deterioration. The development of a procedural approach to quality management, which covers the stages of planning, implementation, monitoring and continuous improvement, is especially important.