Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
News|Articles|September 15, 2019
Why Pharmacopoeia Compliance Is Necessary (PDF)
Author(s)J. Mark Wiggins, Joseph A. Albanese
This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.
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