K.A. Kotegova1

1 All-Russian Scientific Research and Technological Institute of Biological Industry (Losino-Petrovsky urban district, Russia)
1 Federal state enterprise «Shchelkovo biocombinat» (FSE «Shchelkovo biocombinat») (Losino-Petrovsky urban district, Russia)
 

According to the current Rules of Good Manufacturing Practice of the Eurasian Economic Union, the principles of risk management for the quality of manufactured products should be applied to all aspects of the production and use of medical and veterinary medicines. Today, process validation is a continuous, risk-based approach to quality verification throughout the product lifecycle. By applying a risk-based approach, effective planning of validation tests can be ensured. At the stage of development of validation protocols, in order to determine the most critical operations and parameters of the production process, it is necessary to assess the degree of risk of obtaining a poor-quality product, guided by the fundamental principles of risk management for quality. The aim of the work is to determine the list and parameters of validation tests and subsequent verification of the manufacturing processes of immunobiological drugs based on risk analysis. The model object used is the immunobiological preparation "Oralrabivak", produced at the FSE "Shchelkovsky Biokombinat." The work uses standard risk analysis methods, such as the construction of the Ishikawa causal diagram, as well as the analysis of the criticality, modes and consequences of failures. Critical process parameters and quality indicators were identified to determine the necessary and sufficient validation tests and further verification of the production process using the example of packaging of "Oralrabivak" at the FSE "Shchelkovsky biokombinat". The approach described in the work helps to correctly define and rationally plan tests for the validation and subsequent verification of the manufacturing process of immunobiological drugs. A risk-based approach allows you to form a "transparent" concept of the quality of the resulting products and prevent resource losses.

Kotegova K.A. Use of risk-oriented approach in the validation of the manufacturing process of immunobiological drugs. Biomedicine Radioengineering. 2023. V. 26. № 4. P. 49–58. DOI: https:// doi.org/10.18127/j15604136-202302-05 (In Russian)

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