The role of building a unified approach to the pharmaceutical quality system for the harmonious development of the pharmaceutical industry in the EAEU

DOI: https://doi.org/10.29296/25419218-2023-02-04
Issue: 
2
Year: 
2023

V.V. Goryachkin(1, 2), L.I. Grigorova(2), V.I. Gegechkori(2), N.N. Chadova(1), G.M. Rodionova(2)
1-State Institute of Drugs and Good Practices and Good Practices, Lavrov lane, 6/1, Moscow, 109044, Russian Federation;
2-Sechenov First Moscow State Medical University (Sechenov University), Vernadsky ave. 96, building. 1, Moscow, 119571, Russian Federation

Introduction. The publication discusses the relevant model of building harmonized quality management systems (QMS) at pharmaceutical enterprises of the Eurasian Union (EU) countries. Objective: to comprehensively study approaches for the creation of integrated quality management systems at pharmaceutical companies and to define the importance of implementing unified PQS management systems for the harmonious development of the pharmaceutical market in the Eurasian Union. Material and methods. The work is based on a complex analysis of domestic and foreign literature on creating PQS, regulatory documentation of the EU, as well as international ISO quality management standards. Results and discussion. The prerequisites for the development of integrated quality management systems at pharmaceutical manufactures, the advantages of their implementation, are studied. The regulatory framework, on the basis of which PQS is developed, is considered. The paper identifies the challenges facing drug manufacturers and legislative bodies, the solution of which is necessary for the developing of a unified pharmaceutical market of the EU. Conclusion. The principles of building PQS and the elements necessary for its effective functioning are established. The main documents that allow you to properly build a pharmaceutical quality system are the Rules of Good Manufacturing Practice (GMP), ISO 9001:2015 “Quality Management Systems. Requirements” and harmonized tripartite guidance ICH Q10. Was confirmed the key importance of functioning of the unified PQS management system in ensuring the international level of quality of drugs, which are used in the Eurasian Union.
Keywords: 
quality management system
quality management
integrated management systems.
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