Aspects of microbiological monitoring of the production environment in pharmaceutical and biotechnological manufacturing.

This research is devoted to the pressing issue of improving the microbiological monitoring of the production environment and quality control of products in the pharmaceutical and biotechnological industries. It is emphasized that these industries are currently among the most profitable sectors of the Russian economy, but their manufactured products are subject to particularly high quality requirements. The modern operating conditions of these enterprises give rise to certain problems that require a standardized approach to their solution. In this regard, the task of improving the microbiological monitoring of the production environment, as well as quality control of products, becomes particularly relevant in order to optimize production processes and increase the level of safety of the manufactured goods. The paper proposes an approach to the identification and analysis of critical points of production, depending on the sources of potential microbial contamination. For each of the identified critical points, an analysis of potential problems has been carried out, the solution of which will make it possible to increase the effectiveness of the microbiological control system.