Analytical Quality by Design: A Mini Review

Volume 1 - Issue 6

AV Ganorkar and KR Gupta*

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

DOI: 10.26717/BJSTR.2017.01.000484

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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|