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Technical bulletin: Nitrosamine control: understanding the new FDA and EMA regulations

Posted: 16 December 2021 | | No comments yet

This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.

After their detection in 2018, nitrosamines have been a pressing topic in the pharmaceutical world.

Regulatory updates introduced by the FDA and EMA instruct all pharmaceutical manufacturers to conduct a risk assessment and proactively test their products for the presence of nitrosamines. It is crucial for pharmaceutical companies and manufacturers to be updated with these latest requirements.

SGS provides more details on the three-step risk assessment proposed to comply with FDA and EMA methods.

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