ICH guidelines – “Q” series (quality guidelines) - A review
1 RBVRR Women's College of Pharmacy, Hyderabad, India.
2 Gland Pharma Limited, Ameerpet, Hyderabad - 500016, India.
Review Article
GSC Biological and Pharmaceutical Sciences, 2019, 06(03), 089–106.
Article DOI: 10.30574/gscbps.2019.6.3.0034
Publication history:
Received on 03 March 2019; revised on 18 March 2019; accepted on 22 March 2019
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
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Copyright © 2019 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
