USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.
|Articles|July 10, 2023
A Dive into Regulatory Requirements and Strategies for Nitrosamine Testing
Author(s)SGS
There has been a Growing concern among regulators driving a need for awareness for manufacturers to understand the risk associated with nitrosamines in pharmaceutical and biopharmaceutical products. In this session of Changing the Conversation with SGS Live, we tackled a variety of aspects of this important issue from the risk associated with nitrosamine contamination to discovery and mitigation of nitrosamine impurities. Our experts shared the current testing requirements, along with how SGS is helping drug manufacturers along the path of development to ensure their products are free from nitrosamine contamination.
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