I need some information on how to validate a mass spectrometry test method.
Is anyone using mass spectrometry for lot release testing in QA environment
How widely mass spectrometry is used in QA environment now. If there's any
one using MS method for protein/peptide characterization in QA environment,
how are you validating your method, what's the requirements from regulatory
agencies. How are you proving that the method is suitable for it's intended
use, reproducible from day to day and from lot to lot. Any information is
greatly appreciated.
sahar.bahrani@add.ssw.abbott.com
fax 847-938-3701