ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines.
There are other key aspects that must be considered before starting the risk analysis:
• The implementation of this regulation will largely depend on the information available from API and excipient suppliers, so the involvement of API and excipient suppliers in providing this information is required.
• Likewise, it is necessary to include in the technical agreements with suppliers the contribution of elemental impurities and a commitment to assessing the impact on elemental impurities of any changes (in raw materials, processes, equipment etc…); one more reason to have reliable suppliers.
• It will also be critical to define the regulatory strategy (screening, elemental impurities involved, test batches, methods to be validated, etc…), as it could involve a significant cost for the laboratory.
The implementation date of December 2017 for marketed products implies an important workload both in terms of human and economic resources, that must be budgeted for 2017.
At Azierta, we are experts in toxicology and EUROTOX corporate members. Our multidisciplinary team has AETOX, EUROTOX and ERT certified members. We design and develop cus
tomized 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