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A rapid microbiological method case study for advanced therapy medicinal products

European Pharmaceutical Review

The implications of this publication are that the bar for the use of alternative methods is lowered for the products that could benefit from them the most, and in turn, benefits the patients who need therapies as quickly as possible. In 2015, Stacey relocated to the Carolinas, continuing her work in contract laboratory testing.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

As part of the change management process, personnel must manually find, view, and interpret the older data sets to establish a frame of reference for completing method validation exercises and compare the initial and optimized assays. FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation.” 26 Tschorn, U.