Drug substance-related impurities (NDSRIs) in Drug product and Drug substances

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All potential Nitrosamines flagged during risk assessment should be assessed. Please check the post where we discussed the recent FDA Forum where NDSRIs where discussed.

FDA - Generic Drug Forum 2022 (Nitrosamine update)

Next April 26/27 will take place FDA’s Generic Drug Forum - The current state of generic drugs Day 2 - Nitrosamine in Drug Product - An update by Andre Raw - Senior Science & Policy Advisor Register here: FDA Generic Drugs Forum 2022 | SBIA Events [image]