Elemental Impurities - ICHQ3D

1. When will the guideline become effective for authorized human medicinal products?

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.

2. When is it necessary to submit a variation?

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



Further inquiry note