CMC Requirements for New Drug Registration in Latin America
ISPE
MAY 9, 2023
Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. Published 19 January 2005. Published November 2005.
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