US Food and Drug Administration officials recently advised manufacturers to avoid nitrosamine contamination of pharmaceuticals by having adequate control over their manufacturing processes and their supply chains, and by understanding the factors that can affect a drug’s stability over time.
Manufacturers can focus on these areas as the basis for conducting risk assessments, the officials said on 2 October at an FDA small business industry assistance webinar concerning the conditions that may introduce nitrosamine impurities and how risk assessments should be conducted. Much of the discussion was focused on the FDA’s implementation of its recent guidance on nitrosamine testing and risk assessments
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