The new Elemental Impurities Database for Excipients - a valuable support for performing risk assessments according to ICH Q3D

The new ICH Q3D Guideline on Elemental Impurities strongly advocates the use of risk assessments in order to define a final control strategy. Specific challenges appear when risks associated with production equipment, packaging material and excipients have to be determined, and quantified. In particular the contribution of elemental impurities from excipients is not easy to assess due to their big variety and the lack of information from excipient vendors.

Quite recently a pharma consortium started an initiative which aims to collect and share data from pharmaceutical excipients by establishing a database. This Elemental Impurities (EI) Database provides information required for performing a comprehensive risk assessment of a drug product with respect to elemental impurities. Interested companies can contribute to this database by providing information about excipients and may also benefit from this database by taking out information needed for their risk assessments.

The "Impurities Forum" from 27-28 June 2017 in Copenhagen, Denmark provides a comprehensive and practical oriented review of impurities analysis and characterisation in drug substances and drug products. Part II of the Forum on 28 June 2017 is specifically dedicated to Elemental Impurites. In the subsequent post-Conference Workshop on 28 June 2017 the above mentioned EI Database will be explained.

This post-Conference Workshop ideally complements the previous parts of the "Impurities Forum". It is free of charge if you book it in combination with either Part I or Part II or all Parts of the preceding "Impurities Forum".

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