Risk Management in the Manufacturing and Use of the Medical Product for <i>in vitro</i> Diagnostics: Reagent Kit “Lyophilized Erythrocyte Antigenic Tularemia Diagnosticum”

Abstract

The aim of the work was to implement the risk management strategies in the manufacturing and use of medical products for in vitro diagnostics by the example of the experimental series of the reagent kit “Lyophilized erythrocyte antigenic tularemia diagnosticum”.Materials and methods. We tested experimental series of the reagent panel “Lyophilized erythrocyte antigenic tularemia diagnosticum”. To carry out the identification, assessment and analysis of risks regarding the considered medical product, failure mode and effects analysis (FMEA) was proposed and adapted under production conditions. Identification of risks associated with manufacturing and control of medical products for in vitro diagnostics was carried out using technological regulations, standard operational procedures and manufacturing notes.Results and discussion. The main outcome of the study is the development of a corrective actions system aimed at reducing the risks and ensuring consistent monitoring. The proposed schemes for carrying out the risk management process can be used as standard ones in the design and development of medical products for in vitro diagnostics, taking into account the specifics of each individual manufacturing. The reporting documents developed within the framework of the system are applicable during the inspection of good manufacturing practice and in terms of completing the registration profile of a diagnostic product with subsequent registration in the healthcare system of the Russian Federation.