EDQM publishes Update on Heparin Monograph and Policy Paper for dealing with potentially genotoxic Impurities

GMP News
6 August 2008
 

EDQM publishes Update on Heparin Monograph and Policy Paper for dealing with potentially genotoxic Impurities

  
On July 2nd the European Directorate for the Quality of Medicines & HealthCare (EDQM) informed about its latest developments. Immediate action was necessary regarding the revision of two Heparin monographs. These revised monographs were adopted by the European Pharmacopoeia Commission at its 131st session, on 25 June 2008, using the rapid implementation procedure. The implementation date is 1 August 2008. The revised monographs are availabel on the EDQM website

More information:
http://www.edqm.eu/site/News_and_General_Information-43.html

In addition the EDQM published a policy paper for dealing with potentially genotoxic impurities to be applied during elaboration and revision of monographs. Many active substances described in PhEur monographs may contain potentially genotoxic impurities (PGIs) and there is rarely adequate control via the test or tests for impurities (general related substances test or specific test for an individual impurity).

More information:
http://www.edqm.eu/site/News_and_General_Information-43.html

Author:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)


  

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