Since EU authorities were notified about the presence of N-nitrosodimethylamine in Valsartan batches of a Chinese API manufacturer in June 2018, more and more cases of drug substance and drug product batches contaminated with Nitrosamines have come up. During this conference on 18 February 2020 in Frankfurt the relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances and drug products will be discussed.
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The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.