Stability assessment of immunobiological medicinal products manufacturing for veterinary use with Shewhart control charts

Abstract

According to the current Rules of Good Manufacturing Practice of the Eurasian Economic Union, the principles of risk management for product quality must be applied to all aspects of the production and use of medicines for medical and veterinary purposes. The recommended quality risk management method used by regulators is the Shewhart Chart. Control charts, proposed in 1924 by W. Shewhart, are a graphical tool for applying statistical principles to process control. Statistical process control is a methodology for establishing and maintaining production at an acceptable and stable level, providing the required product quality. Control charts are used to collect data during the continuous recording of the characteristics of the quality of manufactured products. As a result of continuous analysis of information, control charts help to identify unusual patterns of data variation and take preventive measures to eliminate them and increase process stability. The use of Shewhart maps leads to a more detailed understanding of the process and helps to discover ways for valuable improvements. The purpose of the work is to assess the stability of the production of immunobiological medicinal products for veterinary use using Shewhart's control charts. The immunobiological drug "Oralrabivak" produced at the Schelkovo Biokombinat FKP was used as a model object. We used control charts of individual values (X-chart) and moving ranges (Rm-chart) and maps of mean values (-chart) and sample standard deviations (s-chart). The assessment of the stability of the production of Oralrabivak using Shewhart's control charts showed that during two production cycles (2021 and 2022) the technological process was in a state of statistical controllability. To improve the process and ensure the quality of the finished product, the specialists of the enterprise have taken preventive measures. The methodology of control charts made it possible to visualize and study in detail a new production process for the enterprise for a deeper understanding of its features by the specialists of the enterprise and further improvement.