Elementary impurities in human medicinal products must be assessed and controlled in accordance with ICH Guideline Q3D. This applies to the entire life cycle of the medicinal product.

In the event of changes that may have an impact on the content of elemental impurities in the finished product (e.g. a new API manufacturer using a different metallic catalyst than previously or a new supplier of a mineral excipient), the corresponding risk assessment, including the established control strategy for elemental impurities, must be re-evaluated (see also ICH Q3D, section 10).

These changes must be evaluated in detail and documented internally as part of the pharmaceutical quality management system.

If required by the relevant Commission guideline, corresponding variations must also be submitted.