Manufacturers Want Delay In Conducting US Nitrosamine Risk Assessments
Pandemic And Volume Of Work Precluding Timely Assessments
Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
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Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.
The AAM has published a position paper on nitrosamines that urges the FDA to revisit and reassess its safety limits for nitrosamines in pharmaceuticals, while also proposing a “science-driven” risk-based approach to evaluate drugs for the potential presence of nitrosamines.
FDA officials say that process and supply chain risks are some of the root causes driving many of the nitrosamine contamination problems in recent months and manufacturers should work to contain and control these risks.