ARTIFICIAL INTELLIGENCE AND ROBOTICS IN PHARMACEUTICAL MANUFACTURING: LEGAL, BUSINESS, AND ENGINEERING CHALLENGES

Abstract

The possibility of applying the concept of Artificial Intelligence (AI) and robotics in pharmaceutical production can transform the speed, precision, and capacity of the latter, yet it is also associated with significant legal, commercial, and engineering concerns. In this work, the author examines the specified issues through a mixed-method study that involves both a secondary analysis of 50 peer-reviewed articles and industry reports as well as primary research of 15 interviews with experts. Key findings have that the largest amounts of companies are a subject to the 72-percentage liability most important legal issue, 63 and 55 percent liability and data privacy, respectively. Critical barriers in business sphere are high capital investment (reported by 78% of the respondents) and workforce adaptation (65%), and work with 58% of the organizations that have issues with strategic alignment. Engineering concerns, namely, system integration, robustness and cybersecurity, scored well with an average impact mark of 4.2 and 4.3 on a 5-point scale. The study also mentions interdependence of domains because the losses and legal violations occur in domains where the cybersecurity is not effective, which explains why it should be taken as a whole. Accepted mitigation measures are consolidated regulatory frameworks, gradual investment strategy, reskilling of employees and high-technology engineering defence.Altogether, the study offers practical recommendations that pharmaceutical companies should use to implement AI and robotics in a responsible way, streamline the processes, and become more innovative and reduce risks.