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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

BioProcess International 14 (2016): 38–43. 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. Smith, and R. Algorri, M., Cauchon, and M.