FDA presses in post-heparin era for more harmonized, QbD-aligned compendia
This article was originally published in The Gold Sheet
A couple of FDA working groups are talking with the U.S. Pharmacopeia about how to better harmonize standards among USP and the European and Japanese pharmacopoeia, FDA's Helen Winkle said in response to a question about a lack of harmonization in their responses to last year's heparin crisis. She told the ISPE Washington conference June 1 that "one of the issues is that as we're changing to quality by design, USP is not changing with us.
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