FUNCTIONAL MAPPING OF THE MEDICINES’ QUALITY CONTROL SYSTEM PROCESSES IN THE SVERDLOVSK REGION

Abstract

The article describes the results of subject-object and risk-based mapping of the medicines’ quality control system. Identification and procedural structuring of key processes of drug quality control systems in Russia was carried out. The matrix of key procedures was formed in coordinates of agency, target, time, and level characteristics for qualitative mapping of the processes and procedures. To quantify the control measures modality in the coordinates "product-context", the structural coefficient of distribution of procedures was calculated for each section of the commodity distribution network: the product emphasis in the production/ manufacturing segment and the environmental emphasis in the system of market distribution of medicines. Based on the results of risk-based mapping, it was determined that the segments of wholesale and retail pharmaceutical activities are characterized by a shift in control measures to the segment of external reactive procedures, which seems to be a negative trend. It is shown that the production of medicines is the leading segment in the implementation of risk-based quality control procedures for medicines, while in the wholesale and retail trade segment this indicator is 95% lower. The key target for optimization measures is the regional wholesale and retail segment of the pharmaceutical market due to the risk-based selective approach to checking compliance with licensing requirements and a large number of control objects.