Whitepaper: Changing Regulatory Environment for Nitrosamine Impurities

[Article Title]

Regulatory agencies worldwide, including the European Medicines Agency (EMA) and US Federal Drug Administration (FDA), released guidance documents outlining risk-based approaches for detecting and mitigating nitrosamine presence. This phased approach includes risk assessment, confirmatory testing, and processes for marketing authorization changes if needed. <br><br>This whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.

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