Elemental Impurities Regulations - View from a CRO

This white paper provides an overview on how the regulations have evolved through the pharmacopeias, how the ICH has impacted these regulations, how these could be implemented by manufacturers and the role of CROs in this process.

Regulatory control of elemental impurities in pharmaceutical products has long been discussed, with both the European Pharmacopeia (EP) and the United States Pharmacopeia (USP) having planned on issuing specific chapters relating to contamination from elemental substances. New regulations have been postponed several times, most recently to take into consideration the guidance from The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). With this document now in place the relevant pharmacopeias are almost certainly finalised as to their respective approaches to the implementation of these regulations.

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