The role of ISO and GMP international standards in management of pharmaceutical company
Keywords:
international standards, pharmaceutical industry, quality management system, ISO, GMP, competitiveness, total quality management, integrated management system, environmental management systemsAbstract
Nowadays modernization of the pharmaceutical industry is not possible without developing the mechanisms of industry management and enterprise management. Thus, while working out the management system, it is highly important to harmonize the company’s business processes with the international standards accepted in the industry. The article deals with the advantages of GMP standards for domestic companies as well as the obstacles that hinder the standard implementation in the Russian market. Moreover, the meaning of ISO standards and their interrelation with the GMP standards are analyzed in the article. The possibility of implementation of several management systems in a company based on the integrated management system (IMS) is also considered.