Elemental Impurity Risk Assessment Study for Paracetamol 500 g Tablet

The ICH Guideline for Elemental Impurities Q3D is come into force for new marketing authorization applications for medicinal products in June 2016 and for already authorized medicinal products in December 2017 (EMA/CHMP/QWP/109127/2015).

The guideline presents a process to assess and control elemental impurities in the medicinal product using a risk assessment approach as described in ICH Q9.

We are following the approach of the Guideline ICH Q3D based on a risk assessment with regard to the finished products by evaluating the impact of metal contamination of all potential sources. The approach followed and level of information provided has to be evaluated based on the identified level of risk in relation to the presence of Elemental Impurities