Toxicological Concern for Impurity Safety.
- Resource Type
- Article
- Authors
- McGovern, Timothy J.
- Source
- International Journal of Toxicology (Sage). 2010, Vol. 29 Issue 1, p124-124. 1/4p.
- Subject
- Language
- ISSN
- 1091-5818
The requirements regarding the safety characterization of impurities in drug substances and products are more formalized and better understood than those for excipient-related impurities even though excipients can often comprise the majority of the overall drug product formulation. Impurities in drug substances and products have been regulated over the previous decade and a half through the International Conference for Harmonization (ICH) Guidances Q3A(R2) and Q3B(R2). More recently, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA and the Center for Drug Evaluation and Research (CDER) of the US FDA released guidance (final and draft, respectively) on how best to deal with genotoxic impurities in drug products. Although ICH Guidance Q3B addresses impurities in new drug products classified as reaction products of the drug substance with an excipient, the guidances currently available specifically exclude impurities arising from excipients. The control of excipient-related impurities is often managed by the manufacturer of the excipient. This session will discuss the regulatory aspects of safety characterization of impurities in drug substances and products and contrast them with the regulations regarding impurities in excipients. [ABSTRACT FROM AUTHOR]