IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM AT THE PHARMACEUTICAL ENTERPRISE THROUGH THE INTRODUCTION OF EFFECTIVE RISK MANAGEMENT

Abstract

Abstract. The article presents the results of the analysis of the production and economic activities of Russian and foreign pharmaceutical companies in order to study modern approaches to risk management within the quality management system. Pharmaceutical enterprises are now actively implementing a quality management system, as this allows you to ensure and control quality at the required level throughout the entire life cycle of a medicinal product. Risk management in the pharmaceutical industry is an important component of the pharmaceutical quality system. Analysis of the position of risk management in the pharmaceutical industry in order to form the basis for the development of guidelines for effective risk management is an important area of research. The purpose of this article was to develop competent organizational solutions for the effective operation of a pharmaceutical enterprise related to the improvement of the quality management system through the implementation of effective risk management. The annual reports of pharmaceutical manufacturers of medicines for medical and veterinary use, pharmaceutical substances and substances used in pharmaceutical production were selected as research materials. The methods of information analysis, induction and synthesis were used as research methods. As a result of the work, a diverse approach of pharmaceutical enterprises to the categorization of risks, an uneven distribution of attention to different categories of risks, their underestimation and the need to develop a risk management manual were established, and measures were proposed to introduce this manual into the activities of pharmaceutical enterprises, including conferences and training courses to improve the competence of organizations in the processes of risk management and the involvement of government agencies in the implementation of risk management.