Implementation of modern quality management system requirements in the production management of reference standards for pharmaceuticals and medicine
https://doi.org/10.17749/2070-4909/farmakoekonomika.2025.311
Abstract
Objective: To summarize current requirements for the quality management system (QMS) in the production of reference materials (RMs) for pharmaceutical and medical applications, as well as to assess the challenges and prospects of system implementation to ensure reliable quality control of medicinal products.
Material and methods. The study analyzed international and national regulatory documents, including ISO 9001, ISO/IEC 17025, ISO 17034 standards as well as good manufacturing practice (GMP) and good laboratory practice (GLP) guidelines. Experiences in QMS implementation at RMs manufacturing enterprises in Russia and abroad was examined. The research methodology was based on a comparative analysis of requirements and practical approaches to quality assurance.
Results. Ensuring RM production quality requires integration of the international standards ISO 9001, ISO/IEC 17025, ISO 17034, and GMP/GLP guidelines. Comparative analysis showed that the Russian quality system in RM production is gradually aligning with the global benchmarks through ISO-based accreditation and international cooperation, while retaining elements of state regulation. Promising directions for QMS development include further harmonization of international standards, digitalization of quality control, and differentiation of RMs to include new medicinal product types. All this necessitates development of novel methodology.
Conclusion. An effective QMS in RM production is a critical factor in ensuring the quality and safety of pharmaceutical products. Integration of ISO standards and GMP/GLP principles enables the production of reference materials with the required accuracy, stability, and traceability, recognized at the international level. Further improvement of the quality system will provide the industry with reliable reference materials and enhance confidence in quality control results both domestically and internationally.
About the Authors
V. I. Gegechkori
Sechenov University
Russian Federation
Russian Federation
Vladimir I. Gegechkori, PhD, Assoc. Prof.
Scopus Author ID: 57060463400
eLibrary SPIN-code: 8964-0804
8 bldg 2 Trubetskaya Str., Moscow 119048
A. M. Sukhanova
Sechenov University
Russian Federation
Russian Federation
Anna M. Sukhanova, PhD
eLibrary SPIN-code: 5811-0044
8 bldg 2 Trubetskaya Str., Moscow 119048
N. O. Belyavskiy
Sechenov University
Russian Federation
Russian Federation
Nikita О. Belyavskiy
8 bldg 2 Trubetskaya Str., Moscow 119048
G. V. Ramenskaya
Sechenov University
Russian Federation
Russian Federation
Galina V. Ramenskaya, Dr. Sci. Pharm., Prof.
Scopus Author ID: 7801436161
eLibrary SPIN-code: 3948-5067
8 bldg 2 Trubetskaya Str., Moscow 119048
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Review
For citations:
Gegechkori V.I., Sukhanova A.M., Belyavskiy N.O., Ramenskaya G.V. Implementation of modern quality management system requirements in the production management of reference standards for pharmaceuticals and medicine. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2025.311
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