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Setting Limits for Genotoxic Impurities in Drug Substances

Authors :
Kirkland, David
Snodin, David
Source :
International Journal of Pharmaceutical Medicine; August 2004, Vol. 18 Issue: 4 p197-207, 11p
Publication Year :
2004

Abstract

In December 2002, the Safety Working Party (SWP) of the European Committee for Proprietary Medicinal Products (CPMP) published a “Position paper on the limits of genotoxic impurities”. The European Union intended to supplement a gap in the International Conference on Harmonisation (ICH) guidelines on qualification of impurities, as it was deemed that impurities with genotoxic potential were a special case not specifically covered in terms of qualification by the Q3A and Q3B guidelines. In fact, the SWP’s proposed approach follows a safety factor-based risk assessment process similar to that in ICH Guideline Q3C on limits for residual solvents, rather than a qualification process as described in ICH Q3A and B.

Details

Language :
English
ISSN :
13649027
Volume :
18
Issue :
4
Database :
Supplemental Index
Journal :
International Journal of Pharmaceutical Medicine
Publication Type :
Periodical
Accession number :
ejs30682024
Full Text :
https://doi.org/10.2165/00124363-200418040-00001