On the Risk of Nitrosamine Contamination during blister packaging

[Naiffer_Host]

If you recall at the “Mitigation Strategies for Nitrosamine Drug Substance Related Impurities” FDA & CRCG) last June, Dr. Justin Moser explained some of Merck’s Nitrosamines Team’s tools and approaches to address the formation risk in Drug Products. (recording and presentation are accessible in the post)

Mitagation Strategy for NDSRIs (FDA & CRCG) Workshop

Next June 15th, FDA and Center of Research on Complex Generics (CRCG) is organizing a hybrid workshop on Mitigation strategies for Nitrosamine Drug Substance Ralted Impurities: Quality and Bioequivelance considerations for Generic Products The purpose of this workshop is to discuss the risks of forming NDSRIs in certain drug products, strategies to mitigate these risks, and considerations in assessing the safety risks of NDSRIs. The workshop will also discuss approaches to prevent or mitigate t…

One of the approaches was around strategies for evaluating the blister packaging process and materials to quantify the risk of Nitrosamines formation.

The presentation referenced a publication by Zheng et al. “On the risk of Nitrosamines Contamination During Drug Product Blister Packaging.”

On the Risk of Nitrosamine Contamination during Drug Product Blister Packaging - Journal of Pharmaceutical Sciences (jpharmsci.org)

The approaches shared in this article are great best practices and can be incorporated into risk assessment for nitrosamine contamination during drug product packaging at other pharmaceutical companies

[MKublicki]

Dear Naiffer,
Would you be so kind as to share the article?
Thank you!

[Naiffer_Host]

You can access the article through the link above…