PRODUCT QUALITY MANAGEMENT AS A STRATEGIC VECTOR FOR ENSURING THE COMPETITIVENESS OF A PHARMACEUTICAL COMPANY ON THE INTERNATIONAL MARKET

Abstract

The article considers alternative views of scientists regarding the essence of the categories of quality, product quality, quality of pharmaceutical products, competitiveness of products and competitiveness of a pharmaceutical company. The scientific problems and modern approaches to understanding these categories are analyzed. A causal relationship between these categories has been established. The components of the problem of product quality management in the aspect of ensuring the competitiveness of a pharmaceutical company are disclosed. The peculiarities of competitiveness in the international market of pharmaceutical companies specializing in the production of generics are revealed. The main factors influencing the competitive position of a pharmaceutical company in the international market specializing in the production of medicines have been identified. From the standpoint of a systematic approach, the author's vision of decomposition of the components of the management system of international competitiveness of a pharmaceutical company has been formed. The composition of its subsystems is substantiated, their goals and objectives are determined, the connection between them is established. It is proved that the international management system is part of Competitiveness includes a number of subsystems, namely: strategic planning subsystem, marketing subsystem, operating subsystem, quality management subsystem and resource subsystem. The quality management subsystem is an important component of the international competitiveness management system and its integration with other subsystems of this system allows balancing the ability of a pharmaceutical company to take a proper competitive position in the international market and the ability to provide an appropriate level of quality of pharmaceutical products to achieve it. The article defines the composition of elements of the quality management subsystem and discloses their goals and objectives. The main elements in the quality management subsystem are defined by the authors: strategy and quality policy, change management, organizational structure and responsibility, management, quality control and audit, personnel development, internal audit, risk management and documentation management. The relationship between individual elements of the quality management subsystem of pharmaceutical companies specializing in the production of generics in the international market is demonstrated. It is proved that the quality management subsystem contains a mechanism of coordination with other subsystems of the management system of international competitiveness of a pharmaceutical company and is an important tool for its competition.