US FDA Sets Out Nitrosamines Guidance
Provides Expectations For Removing Nitrosamines From All APIs, Drug Products
Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.
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Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.
Mylan has hit back at “misleading information” circulating in connection with a recent FDA warning letter – including some statements within the letter itself – as it highlighted its proactive efforts in investigating “all potential risks associated with inquiries related to nitrosamine impurities.”
Concerned about another possible nitrosamine scare, US FDA warning letter to Mylan focuses on firm’s failure to control contamination risks of its APIs and its inadequate testing of reused solvents.