Results of a Survey on ICH Q3D "Elemental Impurities"

One and a half years after the official entry into force of the ICH Q3D Guideline for "Elemental Impurities" and several supporting documents from the ICH (e.g. "Training Package: Modules 0-7") a number of questions as regards implementation remain.

In a survey recently performed by the ECA, questions were posed about the issues relating to the fulfilling of the requirements laid down in ICH Q3D. The feedback from almost 80 participants from medium and large pharmaceutical companies and API manufacturers located in Germany and other EU Member States shows remarkable results which harsh light on the aspects companies have to struggle against with regard to the implementation of the guideline. Please find an extract of this survey below:

• How strong is the impact of the ICH 3D Guideline on your Company?

For more than half of the respondents, ICH Q3D has a strong impact on the company.

• Where do you see the main problems for implementation of ICH Q3D?

For most companies, not only the establishment of safety assessment of potential elemental impurities is seen as problematic but also the analytical procedures for elemental impurities testing required for proving elemental impurities as well as the application of the requirements of ICH Q3D to old products.

• Application of ICH Q3D to existing products is not expected until 36 months after publication. How do you judge this deadline?

Whereas a quarter of the companies surveyed judge the time for application of ICH Q3D to existing products as too short, half of them consider it nevertheless feasible - with great effort though.

The following question clearly shows what support companies especially wish with regard to the problematic:

• What kind of information would you like to receive from ECA in case that ECA would establish an Interest Group?

Examples for risk assessment for elemental impurities would be highly appreciated; besides, also procedure descriptions i.e. SOPs on how to handle the establishment of risk assessment as well as conferences, workshops or forum on that topic have been assessed as very useful.