Thursday 9 June 2022

Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing


In accordance with the CHMP opinion under Article 5 (3) of Regulation (EC) No. 726/2004 on the presence of nitrosamine impurities in human medicinal products, as a precaution, MAHs should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.



MAHs should work with manufacturers of API and finished products in order to review the API and finished product manufacturing processes in light of the arrangements for preventing nitrosamine formation as well as contamination or cross-contamination. This should take into account their knowledge of the manufacturing processes as well as the potential sources of nitrosamine impurities.




Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

1 comment:

  1. Don’t forget about potential contribution from excipients. It’s not just about APIs!


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