Development of comprehensive solutions for managing the risks of a pharmaceutical enterprise while ensuring the quality of medicines based on a survey of specialists

Introduction. The guidelines do not suggest one true path to risk management. Pharmaceutical enterprises develop their own local regulations to ensure compliance with the regulations of the Russian Federation and the EAEU. There are very few studies on how domestic pharmaceutical enterprises solve the problem of introducing a quality risk management system into the enterprise’s quality management system. In this regard, work to study the functioning of the risk management system at Russian pharmaceutical enterprises seems extremely relevant.

Objective. Analysis of the activities of the risk management system for the quality of domestic pharmaceutical enterprises to identify systemic errors in its functioning and the subsequent development of methodological approaches to its improvement within the framework of compliance with current good manufacturing practices.

Materials and methods. Questionnaire method, descriptive statistics.

Results. According to the survey results, the majority of enterprises in the pharmaceutical industry (70.8%) have a system for monitoring and reviewing risks, which indicates a serious approach to risk management. However, almost a third of enterprises (29.2%) do not have such a system, which may indicate possible risks in quality management, as well as the need to implement such systems to ensure more effective control and reduce risks to drug quality. Some domestic enterprises (29.2% of responses) lack systems for monitoring and reviewing risks, which may indicate insufficient control over risks and lack of timely adaptation of the risk management system to changing conditions. The opinion of 52.3% of respondents that the risk management system at their enterprise is formal in nature indicates that the risk assessment system is currently not working effectively enough. The identified problems of the pharmaceutical industry in the field of risk assessment to ensure product quality are formulated: insufficient awareness of employees about some aspects of GMP rules, problems with the distribution of roles and responsibilities when carrying out routine procedures, insufficient theoretical training, inconsistency in the application of standards and procedures, low level of formality in risk assessment procedures, gaps in the understanding and application of risk assessment methods, lack of a systematic approach to monitoring and reviewing risks.

Conclusion. Based on the identified problems, the following proposals were developed to improve the quality risk management system at enterprises in the pharmaceutical industry.