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Sharing Elemental Impurity Data for Excipients Aids ICH Q3D Risk Assessments

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Presented by Grace Kocks.

A consortium of pharmaceutical companies with an interest in the sharing of Elemental Impurity (EI) data for excipients was established in 2015. Lhasa Limited acts as the honest broker and hosts the data in a custom Vitic Nexus database. The use of shared EI data allows more informed judgements during the evaluation phase of an ICH Q3D risk assessment. The EI database represents the largest known collection of data of this type. In the short-term, supportive drug product testing may be used to confirm conclusions of low risk and ensure that appropriate controls have been established. In the longer term, it is envisaged that drug product testing itself will be less frequently required under certain circumstances (e.g. for oral drug products where sufficient data exist to support a conclusion of low risk). Therefore increasing the visibility of data in the database will assist in the overall understanding of EI levels and aid risk assessments.


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