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Adoption and impact of AI-driven statistical process control in pharmaceutical manufacturing: exploring determinants
Dhyey Bhikadiya1, Kirtankumar Bhikadiya2
1Senior Quality Assurance Specialist, Pioneer Life Sciences, East Brunswick, NJ, USA.
Abstract:
The adoption of AI Statistical Process Control (AI-SPC) in pharmaceutical manufacturing case studies that focus on technological infrastructure, organizational readiness, management commitment, and employee acceptance. A quantitative survey of 250 Indian pharmaceutical professionals, analyzed using structural equation modeling and mediation analysis in conjunction with the TOE and UTAUT frameworks. Findings demonstrate that AI adoption readiness, infrastructure quality, employee training, management support, and cost perception considerably enhance process efficiency and improvement of product quality. Employee acceptance partially mediates these effects, thus accentuating the fact that organizational preparedness and leadership commitment are paramount for a successful AI-SPC implementation and improved manufacturing performance.
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