日本PDA学術誌 GMPとバリデーション
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
解説
デジタル技術と生成AIによる知識管理の変革
日本PDA製薬学会 技術教育委員会 CMC・製造DX分科会森川 卓登多賀 駿臺場 昭人朝井 真一久保 光平森本 憲明檜山 行雄
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ジャーナル フリー

2025 年 27 巻 1 号 p. 40-52

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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 日本PDA製薬学会
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