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.
Method Lifecycle Management Library
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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.
The lifecycle of analytical procedures, also known as analytical methods, for pharmaceutical development and manufacture depends on the reliability, robustness, and accuracy of analytical measurements.
Method lifecycle management (MLCM) provides an opportunity to continuously improve and ensure quality of data through the application of quality risk management.