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ASTM E3263 : Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and medical Devices for Residues
ASTM E3263 : Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and medical Devices for Residues
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医薬品製造装置及び医療機器の残留物の目視検査の適格性評価に関するスタンダードプラクティス。医薬品製造装置及び医療機器の残留物の目視検査の検出限界の設定と、検査員の適格性評価のために統計的に有効な手法を示したもの。
医薬品製造装置及び医療機器の残留物の目視検査の適格性評価に関するスタンダードプラクティス。医薬品製造装置及び医療機器の残留物の目視検査の検出限界の設定と、検査員の適格性評価のために統計的に有効な手法を示したもの。
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