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

Olivia Mcdermott,Stephen Daly,Michael Sony,Jiju Antony

doi: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.

Highlights

Introduction published maps and institutional affilManufacturing excellence in the Pharmaceutical and Biopharmaceutical industry is a hallmark of Ireland’s success in the sector
The respondents came from a wide range of functional areas within their organisations. These functional areas contribute to the successful manufacturing and product distribution associated with pharmaceutical manufacture
“very integrated” into their QMS systems. Even these three areas had relatively high combined “very integrated” and “integrated” results of 49%, 37%, and 31%, suggesting that there was still a very high integration of Continuous improvement (CI) methods within these areas even if CI was not as highly integrated there as in other areas. These results suggest a strong focus on CI

Summary

Introduction

Manufacturing excellence in the Pharmaceutical and Biopharmaceutical industry is a hallmark of Ireland’s success in the sector. This sector is constantly driving growth, and Ireland has seen continued capital investment averaging €1 billion per annum over the last 10 years [1]. Ireland is the largest net exporter of pharmaceuticals in the EU, accounting for over 50% of all exports from the country [2]. The sector employs more than 30.000 people in Ireland [3]. The biggest export markets for Irish Pharma products are Europe and the USA, receiving 36% and 30% of Irish pharma exports, respectively [5]

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