Header Artwork
Header Artwork

Whitepaper

WHITEPAPER

How To Handle An Emerging And Unexpected Drug Impurity

To consistently deliver safe and effective pharmaceutical products, processes for impurity control must be established and followed. It is both unfortunate and inconvenient to encounter an unexpected impurity while practicing routine quality control. It requires immediate action to identify, quantify, and assess the impurity, followed by actions to contain the occurrence and manage its effects. Generally these actions involve performing a root cause analysis to establish the source of the impurity and to mitigate, control, or eliminate it. Read this whitepaper to learn more.

Ward d'Autry

Ward d'Autry

PhD, Senior E&L

Ward D’Autry is study director structure elucidation at Nelson Labs, where he manages projects related to the identification of unknown drug impurities using high-end mass spectrometry platforms. The impurities in scope are small organic molecules such as unknown extractables or leachables, drug related impurities or process related impurities in drug substances or drug products From 2017 , Mr. D’Autry works for Nelson Labs Europe as study director. Until 2021, he managed extractables & leachables studies with focus on manufacturing components. In 2021 he transitioned to his current role as study director structure elucidation.

Ruth Verplaetse

Ruth Verplaetse

PhD, Study Director

Ruth Verplaetse received her PhD from the Faculty of Pharmaceutical Sciences at the University of Leuven (Belgium) in 2011. Afterwards, Ruth was active in the field of development and validation of bioanalytical methods with LC-MS/MS. She started at Nelson Labs Europe (formerly Toxikon Europe) in 2016 as study director at the Extractables & Leachables department. In2017, she became part of the Pharma Services Department where she is involved in identifying organic impurities in drug products, stability testing of drug-device combinations as well as development and validation of analytical methods.

Complete the following information to access the whitepaper: