Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...

Thermo Fisher Scientific is providing proteomics and biopharmaceutical research laboratories with a new line of low-flow HPLC columns that improve separation performance and stability of biologically ...

Analytical methods and tools play a pivotal role in cleaning validation. Validating the effectiveness of the cleaning of pharmaceutical manufacturing and process equipment is part of good ...