On September 21, 2023, a virtual joint meeting of the Generic Medicines and Excipients Sectors and European Chapter of the USP Convention on New Nitrosamines Guidances was held. Among the participants was Dr. Natalia VOLOVYK, marking the presence of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines.
The meeting focused on the recent guidances released by the FDA, Health Canada, and the European Medicines Agency on mitigating nitrosamine risks. The session offered a platform for a panel of experts from the United States, Canada, and Europe to discuss these guidances, explore their commonalities and distinctions, and assess their expected impact on patient safety. Attendees also had the opportunity to learn about engaging within the USP Nitrosamines Exchange.
Natalia Volovyk contributed to the meeting, offering insights into the challenges faced by Ukrainian manufacturers of medicines, quality control laboratories and regulatory authorities in light of the new guidances on nitrosamines. Among burning issues are the challenge of setting impurity levels for nitrosamine drug substance-related impurities (NDSRIs), the alignment of the requirements and the problem to stick to the recommended implementation timeline.
Dr Volovyk’s contributions enriched the discussions, offering valuable perspectives on the role of international cooperation in enhancing patient safety and demonstrating the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines’ commitment to quality, safety, and the global exchange of knowledge in the pharmaceutical sector.