At the beginning of this year, the European Medicines Agency (EMEA) published a
question-and-answers document on the limits for genotoxic impurities. It is the
objective of this Q-and-A document to answer frequently asked questions
Guideline on the Limits of Genotoxic Impurities (EMEA/CHMP/QWP/251344/2006).
Question 1 reads:
The guideline does not need to be applied retrospectively to authorised
products unless there is a specific cause for concern. What might constitute "a
cause-for-concern" in terms of application to currently marketed products?
If a manufacturing procedure for API remains essentially unchanged a
re-evaluation with respect to the presence of potentially genotoxic impurities
is generally not needed. However, new knowledge may indicate a previously
unknown cause for concern. One example is the mesylate salt drug substances for
which a few years ago, a concern regarding the potential for formation of
genotoxic alkyl mesylates was raised. This concern resulted in the "Production
Statement" requesting a specific evaluation of the potential for formation of
these highly toxic products now included as part of the PhEur monographs for all
the mesylates salts.
Get more information on impurities and on the guideline on genotoxic impurities
at the ECA Conference:
27–28 May in Prague, Czech Republic.
EMEA's complete Q-and-A document can be found here:
On behalf of the European Compliance Academy (ECA)