Regent Tatiana Mihailovna, Klunko Nataliya Sergeevna, Egorova Larisa Vladimirovna, Chernova Veronika Valeryevna, Meshkova Lyudmila Leonidovna, Kozlov Arkady Artemyevich, Elmira Sungatovna Alpatova


The economic situation in the global pharmaceutical market has undergone profound changes over the past decades, driven by various factors, including the advancement of technology, digitization, emergence of new epidemiological threats, geopolitical conflicts, and more. These factors increase the social significance of pharmaceutical production and stimulate heightened competition, thereby elevating the responsibility of manufacturers for the quality and safety of pharmaceutical products.

In this context, quality issues become vital for pharmaceutical enterprises, shaping the future of pharmacy in the 21st century.

The article explores the issue of quality management in pharmaceutical complex enterprises and substantiates the necessity of implementing the PDCA (Plan-Do-Check-Act) methodology in the operations of pharmaceutical industry enterprises during the regulation and documentation of quality management processes. The advantages that this methodology can provide in achieving the goals of continuous improvement and enhancing the efficiency of quality management system processes are discussed.

This article explores the integration of the PDCA (Plan-Do-Check-Act) methodology into the quality management system of pharmaceutical enterprises, leveraging insights from the ISO 9001 standard. The article offers recommendations for interpreting the PDCA cycle within the framework of ISO 9001 and proposes practical approaches to implementing the PDCA methodology in shaping pharmaceutical quality management systems.


quality management system, Deming-Shewhart cycle, pharmaceutical quality system, ISO 9001 standard, process approach, PDCA, ICH Q10

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