News about GMP/cGMP


EMA: Revised Q&A on Nitrosamine Contamination

End of December 2019, the EMA has updated the Q&A document for marketing authorisation holders who are currently reviewing their medicines for the possible presence of nitrosamines and testing products at risk.

It should support companies in their ongoing review of their manufacturing processes. The 10-page updated document lists potential sources of nitrosamine contamination that have been identified so far and includes four new Q&As.


EMA: Questions and answers on “Information on nitrosamines for marketing authorisation holders”