Abstract

A REVIEW ON ICH GUIDELINES – “Q” SERIES (QUALITY GUIDELINES)

Anand Raj*, Dr. Gaurav Kumar Sharma and Dr. Kaushal Kishore Chandrul

ABSTRACT

ICH - international council for harmonization of technical requirements for pharmaceuticals for human use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH mission is to achieve greater harmonization worldwide to ensure that safe, effective and high quality medicines are developed and registered in the most resource –efficient manner. Harmonization achievements in quality area include pivotal milestone such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more manufacturing practice (GMP) risk management.

Keywords: ICH guidelines; Q- series; Harmonization; Stability studies; GMP, Conclusion.