The ICH Q3D guideline presents a process to assess and control elemental impurities in the drug products. This guideline allows establishing PDE (Permitted Daily Exposure) for each elemental impurity whatever the way of administration. The guideline defines
3 classes of elements depending on toxicity and probability of occurrence in the drug products: Class 1 (As, Cd, Hg, Pb), Class 2A (Co, Ni, V), Class 2B (Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, Tl), Class 3 (Ba, Cr, Cu, Li, Mo, Sb, Sn). The guideline proposes a 3 steps risk-based control strategy:

  • Identify known and potential sources of elemental impurities into the drug product.
  • Evaluate the presence of elemental impurities in the drug product and comparing with the established PDE.
  • Summarize and document the risk assessment. Controls built into the process sufficient or additional controls needed?
The ICH Q3D guideline has been published on the 18th of December 2014. The date for coming into effect is June 2016 for new marketing authorization applications and December 2017 for authorized medicinal products.