Streamlining Postapproval Submissions Using ICH Q12 & SCDM
ISPE
AUGUST 29, 2022
BioProcess International 15 (September 2017):24–47. 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. Published July 2017. Tschorn, U.
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