ICH and USP Agree to Harmonize Metal Impurity Limits

19 Dec 2014

• By Joanne S. Eglovitch

ICH and USP have announced plans to harmonize their limits in pharmaceuticals for elemental impurities like arsenic, lead, cadmium and mercury. An ICH Q3D Step 4 guideline that sets these limits is imminent.

The International Conference on Harmonization (ICH) is expected to soon issue a Q3D Step 4 guidance setting permissible daily exposure limits (PDE) for oral drug products that is aligned with the PDE standards set in the U.S. Pharmacopeia’s Chapter <232>.

ICH Dec. 18 said the guideline had reached Step 4, but as this issue went to press, still had not...