Development of Process-Oriented Quality Management Systems for Pharmaceutical Enterprises
DOI:
https://doi.org/10.70301/CONF.SBS-JABR.2025.1/1.5Keywords:
Process-oriented quality management, pharmaceutical management, pharmaceutical quality system managementAbstract
This study presents a bibliometric analysis of scientific publications on process-oriented quality management systems in the pharmaceutical industry. The aim of the study is to identify key trends, popular topics and gaps in the existing literature. The data were collected from the Web of Science Core Collection, which includes 2147 English-language articles published between 2020 and 2025. The content analysis undertaken in the methodological part allowed to identify the most cited articles related to Pharma 4.0, digital technologies and artificial intelligence-based quality systems. The analysis of the obtained data shows that this research area is still evolving, although it covers a wide range of topics in the pharmaceutical industry. The findings indicated common studies in the areas of productivity, innovation, business process management and quality by design, digital transformation, while in the pharmaceutical sector the focus was often on systematic reviews of drug safety and regulatory practices. The results of this study allowed to define a conceptual framework, content and direction that could become the foundation for future quantitative and qualitative research, highlighting existing gaps and problems in the subject area.
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