14/15 September 2021
In the Q&A part on quality of medicines of the European Medicines Agency's website a question was posted in June 2012 on how to set specifications for (potentially) genotoxic impurities.
Three possible scenarios to this question have been identified.
A potential genotoxic impurity which theoretically can arise during the manufacturing process.
A (potentially) genotoxic impurity which is formed or introduced prior to the final step of the synthesis.
A (potentially) genotoxic impurity which is formed or introduced in the final synthesis step.
For each of these 3 scenarios guidance is given on how to set specifications for (potentially) genotoxic impurities. "Skip lot" testing is also considered as possible.
At the end of the paragraph, you can find a definition of the terms "genotoxic impurity" and "potentially genotoxic impurity".
Regulatory requirements on genotoxic impurities and their practical determination will be one of the key topics discussed at ECA's Conference "Setting Specifications" taking place on 26/27 November 2012 in Barcelona, Spain.
For further information please access the Q&A document on "Impurities - Harmonisation of policies on setting specifications for potentially genotoxic impurities, heavy-metal-catalyst residues and class-1 solvent residues" on the EMA website.