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Quality Risk Management Plans Create Effective Quality Systems
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products...[PharmTech]
EMA Gives Drugmakers Six Months to Assess Products for Nitrosamines
The European Medicines Agency ordered drug companies to review their products within the next six months for contamination with nitrosamines.
Problems With Ranitidine May Transcend Manufacturing Issues
The root cause of NDMA contamination may go well beyond manufacturing problems, to the molecule itself...[PharmTech]
The five potential sources of nitrosamine contamination
With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes...
FDA provides update on testing of ranitidine for NDMA impurities
FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking...