On November 13th, 2023, the US Pharmacopoeia (USP) hosted an insightful 3-hour online event titled “Conversation with USP: Approaches to Developing and Revising General Chapters”. This event featured key speakers and participants from various international pharmaceutical entities, including the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, represented by Olga Tymchenko, Yulia Merkulova, Nelya Kyshynets, and Natalia Volovyk.
Dr. Horacio Papa, Senior Director of the General Chapters Department at USP, led the session, which is part of a series of ongoing discussions aimed at enhancing stakeholder engagement and information sharing about USP operations. The meeting delved into the intricacies of developing USP General Chapters and the critical role of stakeholder participation in these processes.
The meeting also shed light on the shifting focus of pharmacopoeial standards. While 2022 prioritized areas like Analytical Procedure Lifecycle and Continuous Manufacturing, the 2023 focus has expanded to embrace innovative domains like nanomedicines and novel vaccine platforms.
A highlight of the event was the introduction of the Stakeholder Engagement Planning Committee (SEPC). The SEPC, composed of a diverse group of volunteer stakeholders, plays a pivotal role in fostering transparent decision-making at USP. Their efforts span various channels, from social media campaigns to newsletters and workshops, ensuring comprehensive communication and feedback collection.
Another significant point of discussion was the role of Stimuli articles in the Pharmacopeial Forum. These articles, open for proposal by any stakeholder, have been instrumental in stimulating discussion and forming the foundation for General Chapter proposals. This approach underscores the inclusive and collaborative spirit of USP's standard-setting process.
The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines acknowledged the invaluable experience gained from USP, which will be instrumental in the development of the State Pharmacopoeia of Ukraine. This meeting not only highlighted the USP's dedication to global collaboration but also set a benchmark for international engagement in the development of pharmacopoeial standards.