Technical Information

Important changes to the ICH Q3D Guideline

Since June 2016, a risk analysis on the control of elemental impurities in accordance with the ICH Q3D “Guideline for Elemental Impurities” is required on submissions for new approvals, and newly-approved drugs must fulfill the demands of the Guideline. In the case of already-approved drugs, the transitional period is up until December 2017. We repeatedly receive queries on how to handle the tightening of the ICH Q3D Guideline. As a quick overview, we have listed here the most important questions and answers:

How can the new requirements of the ICH Q3D Guideline be fulfilled efficiently and practically?

A careful and prudent risk assessment of the product with regard to potential elemental impurities in combination with well-thought-out analytical measurements is of vital importance. What further measures are required depends on the comparison of the anticipated or measured concentrations of the test with the PDE level permitted by the ICH Q3D Guideline. Depending on the result, further measures are specified, such as establishing a routine measurement.

From what date is the new ICH Q3D Guideline applicable?

The ICH Q3D Guideline applies from June 2016 for new approvals and from December 2017 for approved products that are already on the market. Please also take account of the publications of the “European Medicine Agency” under MA/CHMP/QWP/109127/201, dated February 2015, and under EMA/CHMP/ICH/353369/201, dated July 2016.

What support does BioChem provide for implementation of the ICH Q3D Guideline?

BioChem supports you both in the creation of the risk assessment and in carrying out analytical measurements using ICP-MS or AAS processes. All 24 relevant elements can be analyzed quickly and reliably using ICP-MS. We also make accessible complex test matrices of the measurement with appropriate sample digestion processes.

Which ICP-MS measurements does BioChem offer?

From the point of view of our experts, the so-called screening process has proved to be efficient and practical. The test is handled using a standard sample digestion process, and topped up using a 24-element standard, thereby enabling us to get a first estimate of the element contamination. If an instance of contamination with a value near to the so-called 30% PDE level is detected, we carry out either a limit test or a quantitative test, through which further results are established and validated. When selecting which process to deploy, we always take care to use the best process with regard to cost-effectiveness and safety. In this way, we guarantee an optimum cost-benefit ratio in the implementation of the ICH Q3D Guideline.

Where can further information on the ICH Q3D Guideline be found?

At www.ich.org, the ICH provides a comprehensive Q3D training package, which clarifies all aspects of the Guideline with practical examples. 

Our experts at BioChem are happy to answer further questions on the implementation of the Guideline.