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In early August, the European Pharmacopeia (PhEur) provided clarification on its requirements for heavy metals testing for prod-ucts outside the scope of ICH Q3D, which the pharmacopeia incorporated in April of this year. For products outside the scope of the ICH Q3D guideline such as products for veterinary use, PhEur explains, the absence of elemental impurities tests from an individual monograph on a substance used for their production does not release manufacturers from the need to control the level of such elements in their products, where relevant.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
