A System-Focused Approach to Implementing Continuous Manufacturing in Small Molecule Pharmaceutical Industry in Ireland
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Abstract
This research delves into the integration of continuous manufacturing (CM) within Ireland's small molecule pharmaceutical manufacturing sector, emphasizing a comprehensive approach to understanding benefits, challenges, and opportunities. Through qualitative methods involving semi-structured interviews and thematic analysis, insights from 7 key stakeholders across diverse sectors were gathered. The findings highlight persistent regulatory, technological, and cultural barriers hindering CM adoption, while stressing the necessity of tailored regulatory reforms to support research implementation. Collaboration among stakeholders emerges as pivotal for driving innovation and surmounting challenges. Moreover, the study underscores CM's transformative potential, advocating for investments in technology, workforce training, and streamlined regulatory processes to enhance efficiency and quality control in pharmaceutical manufacturing. Synthesizing stakeholder perspectives with existing literature, the research underscores the importance of a holistic approach, encompassing regulatory reforms, collaborative initiatives, and a culture of innovation, to successfully integrate CM and realize benefits within the Irish pharmaceutical industry.