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Elemental impurities: implementation of a risk assessment strategy

  • At: 2018 FIP Congress in Glasgow (Scotland)
  • Type: Poster
  • By: RITO, Tania (LEF - INFOSAUDE, Quality Assurance)
  • Co-author(s): Duarte Santos: ANF, ANF Director, Lisboa, Portugal
    Fatima Carvalho: Technical & Executive Director, LEF - INFOSAUDE, Lisboa, Portugal
    Tania Rito: Quality Assurance, LEF - INFOSAUDE, Lisboa, Portugal
  • Abstract:


    Elemental Impurities are metal element traces that can be present in drug product and may potentially pose a risk for human health. The guideline “ICH Q3D on Elemental Impurities” introduces new concentration limits for 24 Elemental Impurities, that must be met in newly introduced and already commercialized drug products. ICH Q3D


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Last update 4 October 2019

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