An article which superbly illustrates the concepts and principles of Nitrosamines risk assessment applied to the manufacturing of a drug substance.
Thanks @mflorea !! I want to flag this publication to all our community members.
Secatto et al. l provides a deep dive into a complete and robust risk assessment from the stages of synthesis and equipment evaluation to packaging and stability conditions. Insilico tools are applied and confirmed by analytical testing.
In my personal opinion a great reference publication for folks starting their journey on risk assessment. The publication offer a vast amount of information in the supporting section of the publication.