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Timothy Curran is executive director in process chemistry, Vertex Pharmaceuticals.
J.P. Bercu is senior director in nonclinical safety and pathobiology, Gilead Sciences.
Collaborative industry efforts have shed light on ways industry standards can help pharma companies better understand the risks nitrosamines pose to the supply chain.
IQ Consortium working groups have engaged in ongoing efforts to evaluate risk models and guidance documents to help increase pharma industry knowledge about these impurities.
eBook: Regulatory Sourcebook,
When referring to this article, please cite it as T. Curran and J.P. Bercu, "Managing the Risk of Nitrosamine Impurities," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2021).