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平成 28 年度医薬品の連続生産に ... - nihs.go.jp

28 Points to Consider 1 Points to Consider Continuous Manufacturing

4 連続生産において管理戦略を検討する際は、以下に示す連続生産に特有の管理戦略上の留意点も加味し、開発段階で得られた知識及びリスクアセスメント等を用いて、製品品質に対

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