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EMA Lays Out Plans for Testing for Nitrosamine Impurities

As potentially cancer-causing impurities have been identified in some blood pressure and heartburn medicines, the European Medicines Agency (EMA) is outlining a three-step process whereby manufacturers can identify and control nitrosamine impurities, including N-nitrosodimethylamine (NDMA).
EMA on Monday released new templates for manufacturers to complete as part of their risk evaluations and confirmatory testing. By 26 April 2020, EMA is calling on companies to conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome and fill out either the template indicating “no risk identified” or “risk identified.”
The agency also says manufacturers should perform further confirmatory testing on the products identified to be at risk of N-nitrosamine formation or (cross-)contamination and report confirmed presence of nitrosamines as soon as possible via the appropriate template...[RAPS - EMA]

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