The Nitrosamine impurities crisis prompted regulators around the world to increase their scrutiny of drug manufacturing processes even further. In the future, this greater scrutiny may lead to the discovery of nitrosamine impurities in other medicines. For this reason, manufacturers need to understand which medicines are likely to form nitrosamines, how and at what levels nitrosamine impurities are forming, and how to control nitrosamines. In the following seminar we will explore how USP responded to the nitrosamine impurities crisis not only with a proposed general chapter on nitrosamine impurities but also non-compendial resources and tools that provides a risk assessment strategy, methods for detecting and measuring nitrosamine impurities. In that effort, USP built a knowledge community dedicated to All-things Nitrosamines.
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Naiffer Romero has more than 18+ years of pharmaceutical industry experience. In his 10 years tenure with USP, he has served several roles: Lead scientist in performance testing compendial reference standards development, Manager in charge of LATAM Compendial engagement and education with stakeholders and national regulatory bodies. Romero is also a certified USP Education instructor. Most recently, he joined USP’s Scientific Affairs performance cell where he leads scientific outreach and engagement for LATAM & US region on key national health priority topics. His combined pharmaceutical expertise includes analytical development, salt and polymorph selection, development of dissolution methods, IVIVC modeling, and impurity analytical strategy. Romero also served as member of USP’s Nitrosamine Steering Committee and community host to ‘Nitrosamine Exchange’, a knowledge community in all-things nitrosamine. Naiffer also liaises technical discussions on pharmacopeial collaboration including International meeting of World Pharmacopeias (part of WHO).
Looking forward connecting and sharing with members this new USP initiative