The Egyptian Drug Authority (EDA) announced the conclusion of a workshop on nitrosamine impurities, held in collaboration with the U.S. Pharmacopeia (USP) and featuring American expert Naiffer Romero.

The workshop aimed to enhance participants' understanding of the regulatory and scientific concepts associated with nitrosamine impurities. This was achieved by addressing the latest developments in the field, and providing trainees with the necessary knowledge to evaluate risks, determine acceptable limits, and implement the best relevant regulatory and scientific practices.

During the workshop, multiple topics were discussed, including: an introduction to genotoxic and nitrosamine impurities; control mechanisms for impurities from a regulatory perspective; determining acceptable limits and associated challenges; ICH M7 updates; and a discussion session to answer attendees' questions. The workshop also included case studies for risk assessment, confirmatory tests, available tools and resources in the pharmacopeia, as well as mitigation strategies and future trends.

A total of 60 trainees from the Egyptian Drug Authority's staff across various central departments participated in the workshop, which contributes to preparing a qualified workforce capable of keeping pace with global developments in this field.

This initiative is part of the Egyptian Drug Authority's plan to enhance the efficiency of its technical staff and develop human resources. This effort contributes to improving the quality of health services and supporting the goals of Egypt's Vision 2030, in addition to establishing effective partnerships with reputable international bodies."