International Conference on Harmonisation Guidelines for Regulation of Pharmaceutical Impurities in New Drug Substances

Sunil, Vipin Kumar, Sandeep Ku

Abstract

Pharmaceutical impurities regulation is very important for reduction the risk by evaluation and control of impurities and establishment of acceptance criteria for both drug substance and drug product. Impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established.