Guideline for elemental impurities
International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. At Step 2 of the ICH Process, a consensus draft text or Guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the three ICH regions (the European Union, Japan and the USA) for internal and external consultation, according to national or regional procedures.
