Nitrosamine Control: Understanding the New FDA and EMA Regulations
After their detection in 2018, nitrosamines have been a pressing topic in the pharmaceutical world.
With major regulatory updates introduced by the FDA and EMA, all pharmaceutical manufacturers have been instructed to conduct a risk assessment and proactively test their products for the presence of nitrosamines. It’s therefore crucial for pharmaceutical companies and manufacturers to get up to speed with these latest requirements.
In this technical bulletin, we provide more details on the three-step risk assessment proposed to comply with FDA & EMA methods.