CURRENT ISSUES OF QUALITY MANAGEMENT SYSTEM IN PHARMACEUTICAL PRODUCTION

Abstract

The quality management system (QMS) is one of the prerequisites for successful production activities and serves as a basic mechanism to ensure strict compliance of medical and pharmaceutical organizations in the format of the requirements of applicable standards and regulations. The aim of the work was to analyze the quality management system of pharmaceutical production from the point of view of employees of the enterprise. As an information base the works of domestic and foreign scientists in the field of quality management system, as well as regulatory and organizational documentation on pharmaceutical activities were taken. The questionnaire method served as the main research method, as a result of which 96 employees of pharmaceutical production facilities in Orel, Kostroma, Moscow, Lipetsk and Leningrad regions were interviewed. It was found that from the documents of good manufacturing practices the respondents were most familiar with Good Manufacturing Practices, manufacturing (GMP). The provisions of other good manufacturing practices (GLP, GCP, GSP, GDP, GPP) are mostly unfamiliar to the employees. The majority of respondents believe that the quality of medicines has improved over the last five years, with 56.2% of respondents believing that not all manufacturers comply with good manufacturing practices, explaining that the rules are very complex and it is too expensive for a company to comply with them. The survey found that under the concept of "quality of medicines" employees of pharmaceutical companies mainly mean: safety when used (80.4%); efficacy (79.4%); compliance with the declared characteristics (78.4%). It was found that the specialists of pharmaceutical companies have a positive attitude to the processes of digitalization, but they note the high financial costs at the stages of its implementation and dependence on foreign-made equipment. Thus, we can conclude that the information base in the Russian pharmaceutical production is mainly focused on industry documentation and, to a lesser extent, on related areas; the current industry regulatory framework requires improvement in terms of formalizing processes and specifying requirements.