OPTIMIZATION OF INTERNAL AUDIT IN PHARMACEUTICAL ORGANIZATIONS BASED ON DATA FROM ROSZDRAVNADZOR

Abstract

Aim. Analysis of the results of federal state control in the sphere of medicines circulation to identify systemic violations and substantiate the directions for optimizing internal audit tools of the quality management system of pharmacy organizations.

Material and methods. The study was based on the analysis of official data of Roszdravnadzor on the results of control activities in the sphere of medicines circulation for 2025. Methods of system analysis, grouping of violations by types and risk categories, comparative analysis of scheduled and unscheduled inspections, as well as content analysis of regulatory legal acts governing control and supervisory activities were used.

Results. It was established that in 2025, Roszdravnadzor conducted 150 scheduled and 3,174 unscheduled control measures. Based on the results of scheduled inspections, 460 violations were identified; based on unscheduled inspections — 1,870. The main violations are non‑compliance with the temperature and humidity storage conditions, the absence of a quality management system, violations of the rules for dispensing medications, and violations of the procedure for working in the federal state information system for monitoring the movement of medicinal products. The key indicator of the effectiveness of inspections based on risk indicators amounted to 88.3%. The analysis carried out made it possible to rank the risks of violating mandatory requirements according to the degree of their impact on the quality of pharmaceutical activities.

Conclusion. The identified systemic violations indicate insufficient effectiveness of internal audit in pharmacy organizations. The necessity of optimizing the audit tools of the quality management system taking into account the risk-based approach and typical violations recorded during state control is substantiated.

Financing: The authors declared that there was no source of financing.