Dr. Mark Argentine, Senior Research Advisor of Eli Lilly, discusses the benefits at Analytical Quality by Design, the challenges of identifying impurities and drug degradants, and regulatory and compliance barriers to enhance analytical controls.
In Episode 6, Dr. Phil Nethercote discusses the factors that led to the beginnings of MLCM and QbD in 2004; his early days at GSK and the implementation of MLCM; and how Method Lifecycle Management might evolve.
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
This eBook is a collection of 6 articles covering several aspects of Data Integrity. The principles and strategies outlined can be leveraged to ensure Data Integrity across your laboratory operations.
In this study, the USP impurity monograph for quetiapine fumarate will be analyzed on the ACQUITY Arc System and then scaled to smaller particle sized columns using the Waters Columns Calculator.