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Key factors for the implementation of directive ICH and Q3D on elemental impurities

ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines.

There are 4 issues to be taken into account before starting the risk analysis:

  • The strategies that we follow will largely depend on the suppliers’ baseline information.
  • The number of products requiring risk analysis, which will also influence the strategy to follow because of the impact on human and financial resources.
  • Usually, the pharmaceutical company does not have the analytical equipment for the determination of elemental impurities.
  • Neither the analytical plan nor the analytical cost can be considered without having analysed all the available baseline information.

On a practical level, the process for completing the risk analysis is as follows:

The implementation date of directive ICH Q3D on elemental impurities of December 2017 for marketed products will involve an important workload both in terms of human and economic resources.

At Azierta, we are experts in toxicology and EUROTOX corporate members. Our multidisciplinary team has AETOX, EUROTOX and ERT certified membersWe design and develop customized action plans for the implementation of ICH Q3D of elemental impurities, with a background of more than 600 reports completed or in progress, both on a national and international basis, which have already been assessed by health authorities.

Visit our website and fill out our form to gain access to practical advice on the implementation of ICH Q3D on elemental impurities.

If you would like to know more about us, please visit: Elemental impurities risk analysis


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