Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

Olivia McDermott, Jiju Antony, Michael Sony, Stephen Daly

    Research output: Contribution to journalArticlepeer-review

    26 Scopus citations


    This study aims to investigate the barriers that exist when implementing continuous improvement methodologies, such as Lean Six Sigma (LSS), within the Irish Pharma industry. The main finding of this study is that 45% of participants perceived that a highly regulated environment could be a barrier to continuous improvement implementation, while 97% of respondents utilised Continuous improvement (CI) methods, such as Lean, Six Sigma, and LSS, within their organisations. While the International Conference of Harmonisation integrates CI into its Pharmaceutical Quality Systems (PQS) regulations, the highest motivation for CI implementation amongst the Irish Pharma industry is to improve Productivity and Quality. The main obstacles highlighted for CI implementation in Pharma attributed to stringent regulatory regimes were fear of extra validation activity, a compliance versus quality culture, and a regulatory culture of being “safe”. Another relevant finding presented in this paper is that participants CI LSS tools are very strongly integrated into the pharma industries corrective and preventative action system, deviations, and internal audit systems. Limita-tions of the research are that all the data collected in the survey came from professionals working for multinational Pharmaceutical companies based in Ireland. The authors understand that this is the first research focused on the barriers and status of CI initiatives in the pharmaceutical industry. The results of this study represent an important step towards understanding the enablers and obstacles for the use of continuous improvement methodologies in pharmaceutical manufacturing industries on a global scale.

    Original languageBritish English
    Article number73
    Issue number1
    StatePublished - Jan 2022


    • 21 CFR 210
    • 21 CFR 211
    • Biopharmaceutical industry
    • Continuous improvement
    • European Medicines Agency
    • Food and Drug Administration
    • International Conference for Harmonisation (ICH)
    • Lean six sigma
    • Pharmaceutical industry
    • Pharmaceutical Quality System (PQS)


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