Elemental impurities: implementation of a risk assessment strategy

• At: Glasgow (Scotland) (2018)
• Type: Poster
• Poster code: POS-ASP-012
• 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:

  Background

  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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