*Corresponding author:
K.R Gupta, Department of Pharmaceutical Chemistry, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, IndiaReceived: October 25, 2017; Published: November 01, 2017
DOI: 10.26717/BJSTR.2017.01.000484
To view the Full Article Peer-reviewed Article PDF
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|