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Elemental Impurities FAQs

This FAQs section details frequently asked questions about the Elemental Impurities database.
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Is this database accepted by a European Authority of pharmaceutical products?

Records in the database can be considered to have equivalent provenance to information found in the published literature. ICH Q3D Section 5.5 lists published literature as a source of information to be used in risk assessment. Members of the consortium reference the database within their risk assessment summary which is sent to regulators. The consortium has been engaging with European regulators to increase awareness and acceptability since 2016 and have introduced six regulatory bodies to the initiative.

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