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Setting Limits for Genotoxic Impurities in Drug Substances
- 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