Analytical Quality by Design: A Mini Review

AV Ganorkar and KR Gupta*

Received: October 25, 2017;   Published: November 01, 2017

DOI: 10.26717/BJSTR.2017.01.000484

Full Text PDF

To view the Full Article   Peer-reviewed Article PDF

Abstract

According to ICH Q8 guidelines, QBD is “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.”

Abbreviations: QbD: Quality By Design; ATP: Analytical Target Profile; HPLC: High Performance Liquid Chromatography; UV: Ultraviolent Rays; GC: Gas Chromatography; QCA: Critical Quality Attributes; MODR: Method Operational Design Region

Introduction| Elements of AQbD| Risk Assessment| MODR (Method Operational Design Region)| Method Control Strategy| Lifecycle Management| Conclusion|