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Barriers and enablers for continuous improvement methodologies within the Irish pharmaceutical industry

McDermott, Olivia
; 
Antony, Jiju
; 
Sony, Michael
; 
Daly, Stephen
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http://hdl.handle.net/10379/17079
 https://doi.org/10.13025/18188
Publication Date
2021-12-30
Keywords
continuous improvement, pharmaceutical industry, biopharmaceutical industry, lean six sigma, 21 CFR 211, 1 CFR 210, International Conference for Harmonisation (ICH), Pharmaceutical Quality System (PQS), European Medicines Agency, Food and Drug Administration
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Article
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McDermott, Olivia, Antony, Jiju, Sony, Michael, & Daly, Stephen. (2022). Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry. Processes, 10(1), 73. ttps://doi.org/10.3390/pr10010073
Abstract
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. Limitations 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.
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MDPI
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CC BY-NC-ND 3.0 IE
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Biomedical Engineering (Scholarly Articles)