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
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.