Andrew Teasdale

This article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.