橋渡しガイドラインと規制:GMP製造における人工知能に関する附属書22号草案の解釈
Mario Stassen1, Matt Schmucki2, Fransisco Barranco3
1Department of Life Sciences Innovation, Stassen Pharmaconsult BV, Aerdenhout, The Netherlands.
PDA journal of pharmaceutical science and technology
|February 16, 2026
まとめ
この論文は,医薬品製造のための人工知能 (AI) に関する欧州医薬品庁の附属書22号草案を解釈しています. それは,AIの採用を,規制の遵守のための継続的なプロセス検証 (CPV) の勧告と一致させる.
科学分野:
- 製薬製造業 製薬製造業
- 規制科学 規制科学とは
- 人工知能 (AI) とは,人工知能 (AI) のことです.
背景:
- 製薬業界はますます人工知能 (AI) を採用しています.
- 継続的なプロセス検証 (CPV) は,AIアプリケーションの枠組みを提供します.
- 欧州医薬品庁 (EMA) は,医薬品製造におけるAIに関する附属書22号草案を公表した.
研究 の 目的:
- GMP規制の製薬製造におけるAIに関するEMAの草案附属書22の解釈について.
- 附属書22とCPVの勧告との連携を検証する.
- AIに準拠する実装のためのロードマップを提案する.
主な方法:
- EMAの文献レビューと解釈 附属書22 草案
- 附属書22とCPVの勧告との調和の分析 (Stassen et al., 2025).
- 概念的フレームワークとワークフローのイラストの開発.
主要な成果:
- 附属書22とCPVの原則との収束が確認されました.
- AI導入における運用上の課題を強調した.
- 調和したAIガバナンスとコンプライアンスのためのロードマップを提案した.
結論:
- EMAの草案付録22は,医薬品製造におけるAIのリスクベースの枠組みを提供します.
- CPVの原則を,附属書22の期待事項と調和させることは,コンプライアンスにとって極めて重要です.
- プロアクティブなAIガバナンスは,製薬部門の準備に不可欠です.
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