Quality management in forming the integration capability of pharmaceutical enterprises
DOI:
https://doi.org/10.26661/2522-1566/2026-3/37-05Keywords:
pharmaceutical enterprises, quality management, pharmaceutical quality system, integration capability, global value chains, GMP, WHO prequalification, technology transfer, licensing, transaction costsAbstract
The study examines the role of quality management in creating the integration capacity of pharmaceutical enterprises, defined as their ability to perform international production, licensing, and technological functions. The article aims to substantiate and empirically specify how quality management develops the integration capacity of pharmaceutical enterprises. Methodology: combines institutional and regulatory analysis with a comparison of documented corporate cases. The sectoral level is characterized based on the public report of the State Service of Ukraine on Medicines and Drugs Control on its activities in 2022. At the enterprise level, the analysis focuses on events from 2020–2022 for which the nature of the international function, the date, and the source of verification - whether an international organization, a license holder, or the enterprise itself - can be established unambiguously. This approach makes it possible to link quality requirements to specific forms of international participation without constructing a universal ranking of enterprises. Results: The study systematized the economic channels through which the Quality Management System influences international functional participation; characterized the regulatory framework governing pharmaceutical manufacturing in 2022; compared documented cases of external quality assurance, licensing, and technology transfer in 2020–2022 with the corresponding international functions; and, as an additional validation, examined the relationship between the specific WHO PQ product signal and short-term accounting profitability in 2021–2022. Practical significance: The practical implementation of the proposals and conclusions of this article should be considered in the context of their importance for ensuring effective quality management within the development of the integration capacity of pharmaceutical enterprises in Ukraine. Uniqueness/value: The scientific study proposes distinguishing between two economic channels of the quality management system at pharmaceutical enterprises in Ukraine: the threshold channel, where verified quality is a mandatory condition for access to a specific product-market route, and the transactional channel, when managed processes, risks, data, and technology transfer reduce uncertainty in interactions between partners.
JEL класифікація: F15, L15, L65, M11.
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