New Guidelines for Controlling Impurities
EMA reviews lessons learned from nitrosamine impurities
Following a “lessons learned” exercise, the European medicines regulatory network has published recommendations to reduce the risk of drug impurities. The recommendations clarify companies’ roles and responsibilities when it comes to controlling, detecting, managing, and communicating impurities.
In mid-2018, nitrosamines present in some sartan medicines led to recalls and other regulatory measures. The impurities came from the use of dimethylformamide and sodium nitrite, which, in the presence of an acid, led to the formation of N-nitrosamines during API manufacture. EMA also identified the potential for contamination from other sources. Although nitrosamines were not previously recognized as impurities in sartan medicines, animal studies show that they are a probable human carcinogen. As a direct result, the “lessons learned” exercise was launched to explore how unexpected impurities could be prevented and, if they do occur, how to manage them in the future.
The recommendations are available on the EMA website: www.ema.europa.eu
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