PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Topics Review
The Transformation of Knowledge Management through Digital Technologies and Generative AI
PDA Japan Chapter, Technical Education CommitteeTakuto MORIKAWAShun TAGAAkito DAIBAShinichi ASAIKohei KUBONoriaki MORIMOTOYukio HIYAMA
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2025 Volume 27 Issue 1 Pages 40-52

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Abstract

This study addresses challenges in pharmaceutical manufacturing, including quality assurance, regulatory compliance, rising costs, complex supply chains, and a skilled labor shortage. The increasing demand for advanced knowledge complicates the transfer of skills, while tacit knowledge accumulation remains inadequately formalized and shared. To tackle these issues, we propose the implementation of AI-driven knowledge management tools that enhance knowledge visibility and facilitate effective knowledge transfer. Drawing from the ICH-Q10 definition of knowledge management, we emphasize the importance of not only sharing information but also ensuring its usability by recipients. This research investigates the effectiveness of these digital solutions in improving knowledge management in the pharmaceutical industry.

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© 2025 Parenteral Drug Association Japan Chapter
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