The
ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in
December 2013 and now enters the implementation period (Step 5). This new
guidance has been developed to provide a global policy for limiting metal
impurities qualitatively and quantitatively in drug products and ingredients.
The existing ICH Q3A Guideline classifies impurities as organic, inorganic, and
residual solvents. The Q3A and Q3B Guidelines effectively address the
requirements for organic impurities. An additional Guideline Q3C was developed
to provide clarification of the requirements for residual solvents. The new Q3D
Guideline would provide similar clarification of the requirements for metals,
which are included in the ICH inorganic impurities classification.
Posted by Tim Sandle
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