Guideline ICH Q3D, which addresses the requirements regarding elemental impurities of human medicinal products, is effective for authorised human medicinal products since 1st December 2017.

A risk analysis regarding elemental impurities of the finished product should be performed, documented and be available on-site. Submission of a variation is only necessary, if the risk analysis shows that:

• the control strategy has to be changed (including changes to already existing controls)

• changes in the manufacturing process are necessary

• materials have to be exchanged or changes in material quality are necessary