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

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