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IMPLEMENTATION MPLEMENTATION OF ICH Q3D:

With the publication of the 9th  Edition of the European Pharmacopoeia, the reference to general chapter  Heavy metals  (2.4.8) has been deleted from individual monographs on substances for pharmaceutical use, except from those for veterinary use only. This completes the first step of the Ph. Eur. strategy for implementing the implementation of the ICH Q3D guideline on elemental impurities.

To learn For more information on the implementation of this guideline within the Ph. Eur., please consult see the following documents:

Press release: Ph. Eur. on elemental impurities on elemental impurities (April 2015)

Press release: Ph. Eur. on elemental impurities policy on elemental impurities - clarification for products outside the scope of the ICH Q3D guideline (August 2015)