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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eBook
eBook | Understanding Data Integrity in Your Laboratory Operations
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.
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App notes / Tech briefs
Scaling a USP Gradient Method on the ACQUITY Arc System in Support of Lifecycle Management
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.
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Blogs / Articles
Future-Proofing Pharmaceutical Analytical Method Development With an AQbD Approach
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.
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Blogs / Articles
An increased focus on lifecycle management for analytical methods has been seen in recent years from the industry’s regulatory bodies.
Building a New Business Model with Method Lifecycle Management
Method lifecycle management (MLCM) provides an opportunity to continuously improve and ensure quality of data through the application of quality risk management.
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