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. 2013/C 223/01. Published 8 February 2013. Decree 677/1995.
52 
Let's personalize your content