US Pharmacopeia

On #WorldStandardsDay, we proudly join ISO - International Organization for Standardization, ANSI - American National Standards Institute, and many others to celebrate our shared vision for a better world, made possible through public quality standards. Today and every day, we are grateful for—USP Expert Volunteers—the global network of independent scientists who are at the heart of US Pharmacopeia's standards development, review, and revision process. From all of us at USP, we say thank you to each #USPExpertVolunteer for the commitment, scientific rigor, and passion that advance our quality standards and global #PublicHealth. And we invite you to join us and help advance quality-assured medical products, equitable and accessible care, pharmaceutical innovation, supply chain resilience, and a healthier, safer world for all. Apply to volunteer with USP in 2025-2030: Bit.ly/USPExpertVolunteer #ProudToBeUSP #Standards4SDGs

We are excited to announce the successful conclusion of the Fourth MENA Regional Chapter Meeting of the USP Convention, held on Tuesday, October 15, 2024. This hybrid event, hosted by the Jordanian Association of Pharmaceutical Manufacturers (JAPM) in Amman, Jordan, brought together 32 representatives from regulatory bodies and pharmaceutical associations across the Middle East and North Africa. The meeting began with a warm welcome from Alessandro Slama, USP’s Vice President of Regional Program Operations, followed by an insightful update from Hanan Sboul, MENA Chapter Chairperson and General Secretary of JAPM, on the chapter’s activities and upcoming transition. Zakiya Kurdi, USP’s Director of Public Policy and Regulatory Affairs for EMEA, then provided a comprehensive overview of joint initiatives between USP and its convention members since the last chapter meeting. A key part of the event featured presentations by convention members, who shared their organizational priorities and explored how USP can support their efforts. Esteemed speakers represented key bodies, including the Egyptian DA, Jordanian FDA, Abu Dhabi Department of Health, Drug Department of Dubai, Algerian NPP, Morocco DMP, Tunisian LNCM, Saudi Pharma and Bio Cluster, Chamber of Pharmaceutical Industry Egypt, and Arab Union of Pharma Manufacturers AUPAM. The discussions highlighted shared priorities and laid the groundwork for ongoing collaboration to enhance medicine quality across the MENA region. We extend our sincere gratitude to all participants for their valuable contributions and look forward to continuing our collective efforts to advance regulatory and pharmaceutical standards in the region

⏱ We're looking forward to #GRxBiosims2024! For all attendees, make sure you visit us at our exhibit booth and the USP Impact Business Lounge and don't miss presentations by USP experts Diane McCarthy and Hong Wang!

In the aftermath of Hurricane Helene, USP is providing resources, with input from our Compounding Expert Committee, intended to support healthcare practitioners and scientific professionals to address shortages of manufactured intravenous fluids: 1️⃣ Operational considerations for sterile compounding by pharmacy compounders not registered as outsourcing facilities during public health emergencies and natural disasters 2️⃣ Complimentary USP monographs for use during a public health emergency Click here to download the free resource ➡ : https://ow.ly/N9uh50TNCka #USPScience

Last week, USP hosted a group of students and faculty from the Howard University College of Pharmacy for a second year. This visit served as an enriching day of learning and discovering career opportunities in pharma that extend beyond traditional pharmacy roles. During a panel discussion with USP leaders, (including Anthony Lakavage, Sr. Vice President, Global External Affairs, and a member of the college's Board of Visitors), students engaged in discussions about the evolution of the pharmacy profession. They also toured our state-of-the-art labs, where they witnessed firsthand the thorough work of USP scientists that help ensure the quality and safety of medicines. They also received first-hand education from USP staff about our history and the impact of quality and standards on pharmacy. We are proud to be a part of their journey where they will drive innovation and improve patient care through their passion and dedication. Thanks to all who participated! #ProudToBeUSP

#USPScience: Are you passionate about the quality of dietary supplements? Be part of USP’s standards development process by submitting your comments on the below proposed General Chapters revisions relevant to dietary supplements by November 30, 2024: <202> Identification of Fixed Oils by Thin-Layer Chromatography <2021> Microbial Enumeration Tests - Nutritional and Dietary Supplements <2022> Microbiological Procedures for Absence of Specified Microorganisms - Nutritional and Dietary Supplements Submit your comments here: https://ow.ly/Ktap50TGRAh

USP recently hosted a hybrid event in collaboration with the Jordan Food and Drug Administration المؤسسه العامه للغذاء والدواء الأردنيه (JFDA) on October 14, at the Hilton Amman. With 120 attendees joining in person and 35 virtually, this event brought together key stakeholders from regulatory bodies in the region, the pharmaceutical industry, and the Jordanian Association of Pharmaceutical Manufacturers (JAPM) for a day of engaging discussions and insightful recommendations. The event kicked off with a warm welcome from Alessandro Slama, USP Vice President Regions RPO and Zakyia Al-Kurdi, USP GEA-EMEA Director, Dr Maha Jaghbeer, Director General Assistant of JFDA and Dr. Hanan Sboul, General Secretary of JAPM and USP Chairperson for MENA Regional Chapter. It was followed by a series of engaging sessions that delved into the most pressing topics in the pharmaceutical industry today. 🔍 Session 1: We explored the critical role of reference standards in ensuring the quality of medicines and discussed strategies for mitigating risks to pharmaceutical quality with case studies and real-world applications. 🔬 Session 2: The discussions focused on the evolving frameworks of USP and JFDA, highlighting the latest updates and their implications for the industry such as nitrosamines testing, excipient adulteration like EG/DEG, and updates in USP. A special thank you to AL MASSAT LIFE SCIENCES - Official USP Distributor - MENA, our authorized distributor, for their invaluable participation in organizing this event. Your support was instrumental in making this event a success. USP looks forward to continuing our journey towards ensuring the highest standards in pharmaceutical quality.

Attending Developing Countries Vaccine Manufacturers Network (DCVMN International)'s Annual General Meeting next week? Don’t miss USP’s session where USP's Laura B. Martin, PhD and Afrigen Biologics (Pty) Ltd’s Petro Terblanche will discuss regulatory challenges faced by vaccine manufacturers in LMICs, highlighting experiences from African manufacturers. This session will also explore ways to build regulatory capacity for vaccine approval for market use. USP will also be presenting alongside other global health experts in a session to highlight new vaccine technologies, including novel applications in mRNA manufacturing and vaccine delivery. Kevin Carrick will highlight the role of quality standards for manufacturers and regulators that support quality-assured manufacturing, packaging, and release processes for vaccines. If you’ll be in Sao Paulo for #AGM2024, be sure to connect with our team to learn how USP is working to expand access to quality-assured vaccines and biologics. Learn more: https://ow.ly/NlFG50TGICj

As we prepare to celebrate #WorldStandardsDay 🎉 next week, we thank all who help make our system one worth celebrating. The U.S. regulatory system sets the bar globally so that patients receive safe, quality medicines. Trust in our medicines supply chain is earned daily through FDA’s rigorous oversight, industry commitment to and investment in quality, and adherence to US Pharmacopeia public quality standards. The USP-FDA relationship dates back to the 1906 Pure Food and Drug Act, which deemed the United States Pharmacopeia and the National Formulary official compendia under federal law. Scroll ⤵️ to see how USP and FDA work together to help make sure that U.S. medicines are among the safest in the world. Join us in celebrating with a #Repost to spread the word and learn more: Bit.ly/FDAandUSP #FDA #Collaboration #Standards

Strong regulatory systems are critical to improving access to safe, quality-assured medical products. With support from Bill & Melinda Gates Foundation, we're excited to work with Food and Drugs Authority,Ghana to develop a continental training hub for regulators across #Africa. Learn more about the project ➡: https://ow.ly/x6B950TGR5B