RISK MANAGEMENT IN THE PRODUCTION OF DRUGS FROM HUMAN BLOOD PLASMA: START STRATEGY, ANALYSIS AND RECOMMENDATIONS

The article presents a strategy for the implementation and continuous development of a risk management system aimed at minimizing potential threats related to the biological nature of raw materials and the complexity of multi-stage technological processes faced by a pharmaceutical company manufacturing medicines from human blood plasma. A survey was conducted with the participation of 30 employees from various departments of the company. Based on the collected data, ten hypotheses were formulated and tested on issues such as employee awareness of regulatory documents, involvement in risk analysis processes, staff training, and the integration of risk management into daily activities. The study identified important areas for the risk management system, including increasing employee awareness, increasing management engagement, improving access to instructions and regulations, and integrating risk management into routine activities. Recommendations were proposed for building a system with an emphasis on improving product quality, ensuring safety and compliance with regulatory requirements. This study highlights the importance of continuous development of the risk management system and quality management system in a pharmaceutical company, as well as the importance of an integrated approach to risk analysis, including both quantitative and qualitative methods. The implementation of the strategy proposed in the study will allow: 1. Improve the sustainability of production processes and the level of control at all stages of the product lifecycle; 2. Minimize production risks and the likelihood of critical deviations; 3. Ensure compliance with international standards; 4. To increase the level of patient health protection.