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US FDA Expectations For Removing Nitrosamines From All APIs, Drug Products

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Executive Summary

Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.

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Drug GMP and CMC Updates In Brief: Guidance Advances on Several Fronts

The US FDA revised two drug good manufacturing practice inspection programs in its compliance manual to reflect certain ICH guidance documents, efforts to control nitrosamine impurities and the use of inspection alternatives for evaluating facilities. Plus more recent developments in GMP and CMC compliance.

USP Nitrosamine Impurities Chapter Reflects Coordination With EU As Well US Agencies

The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.

USP Nitrosamine Impurities Chapter Reflects Careful Coordination With US, EU Authorities

The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.

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