In recent months, both the World Health Organization and Health Canada | Santé Canada released draft or updated guidances related to nitrosamine impurities in pharmaceutical products. The last year has seen a whirlwind of updates from other regulatory agencies as well. In light of these developments, Quality Matters sat down with Mrunal Jaywant, who leads USP’s global work on nitrosamines, to talk about where the industry currently stands in regard to overcoming the challenges posed by these impurities. Read more about where she sees things currently, and what she sees ahead for the future ➡️: https://ow.ly/lEFK50SyMzQ
US Pharmacopeia
Pharmaceutical Manufacturing
Rockville, Maryland 160,132 followers
The Standard of Trust.
About us
US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820. We are a public health organization that uses rigorous science and public quality standards setting to protect patient safety and improve global health. We are committed to building public trust and confidence in drug therapies to enable people to live longer and healthier, and also work to building trust in dietary supplements and food ingredients. Currently, we are working to strengthen the global supply chain so that the medicines people rely on are available when needed and work as expected. Our Volunteers USP standards are in a continuous process of review and revision based upon new evidence, emerging public health concerns, and public requests for revision. Input from our volunteers, through our Council of Experts and Expert Committees and Panels, is crucial for maintaining our standards and preserving public trust. Our Governing Bodies The USP Convention helps guide our areas of impact – nearly 500 Member Organizations from around the world contribute valuable perspectives, experiences, and expertise from across healthcare and science. In addition to collaborating on critical healthcare and science matters, every five years, Convention Members adopt USP Resolutions and elect USP’s Board of Trustees and the Council of Experts who lead USP’s standards-setting Expert Committees. Visit www.usp.org to learn more.
- Website
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http://www.usp.org
External link for US Pharmacopeia
- Industry
- Pharmaceutical Manufacturing
- Company size
- 1,001-5,000 employees
- Headquarters
- Rockville, Maryland
- Type
- Nonprofit
- Founded
- 1820
- Specialties
- Product Quality–Standards and Verification, Healthcare Information, pharmaceuticals, Medicines quality, medicines safety, substandard medicines, falsified medicines, Medicines Supply Chain, COVID-19 Vaccines, Pharmaceuticals Advanced Manufacturing, and Pharmaceuticals Continuous Manufacturing
Locations
Employees at US Pharmacopeia
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Shelley Whiddon
Building and implementing strategic initiatives that engage stakeholders and achieve results
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Scott Bolgiano
Senior Manager, Publishing Technology at USP, the United States Pharmacopeia
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Melanie V, CIR
Senior Talent Acquisition Partner
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Stu Kim
Legal Counsel - Pharmaceutical at Catalyst Pharmaceuticals, Inc.
Updates
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Proud to have partnered with USAID & JSI to strengthen #TB medicine supply chains, ensure quality drug procurement, improve quality surveillance of #TB medicines & strengthen #HealthSystems. Read the blog: https://ow.ly/yWk550Sxa6B
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To support increased access to quality medicines and vaccines in Africa, we launched #USPAccess4Africa, in collaboration with Africa CDC African Union Development Agency-NEPAD the Association of African Universities and the Federation of African Pharmaceutical Manufacturers Associations (FAPMA). The initiative aims to strengthen the region’s pharmaceutical ecosystem and manufacturing capacity by offering complimentary access to United States Pharmacopeia National Formulary (USP-NF) and the USP Education training library for African-based: ✅ Regulatory authorities, ✅ Laboratories, ✅ Academic institutions, and ✅ Manufacturers. Learn more and register to get started today: Bit.ly/USPAccess4Africa
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In many low- and middle-income countries, quality-assured medical devices are often unavailable, unaffordable, or of poor quality. That’s why the USAID-funded PQM+ program is working with local manufacturers in #Nepal, #Bangladesh, and #Pakistan to produce a range of products, from basic medical supplies to more specialized equipment. Explore the interactive story: https://ow.ly/YlEc50SyN18
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“It’s being part of a community dedicated to advancing health and connecting with people who share your passion for science and quality medicines for all.” 💬 Carla Juliani, USP Expert Volunteer What sets volunteering with US Pharmacopeia apart from other career development and service-leadership opportunities tailored for pharmaceutical sciences professionals? Hear more about Carla’s experience as a member of Brazil's medical manufacturing sector and get inspired to amplify your impact through the power of our global, cross-disciplinary community. Get started today by applying to serve as a #USPExpertVolutneer in our upcoming 2025-2030 cycle: Bit.ly/USPExpertVolunteer #ProudToBeUSP #PublicHealth
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Reliance models are an essential component of achieving regulatory harmonization. We are looking forward to next week's workshop where US Pharmacopeia's Kwasi Boateng will highlight progress toward regulatory reliance and the importance of complimentary regulatory capacity building at all levels. Thanks to the U.S. Trade and Development Agency (USTDA) and Corporate Council on Africa for organizing this workshop series on regulatory harmonization. Learn more: https://ow.ly/Eq1K50SyTq6
USTDA is hosting a two-day workshop July 16-17 in Abuja, bringing together U.S. and West African pharmaceutical and medical device companies, along with government officials. Register to engage with health regulatory leaders and industry experts to advance regulatory harmonization and improve market access for medical products in Africa: https://lnkd.in/eUJtaub4 #HealthcareInnovation #WestAfrica Corporate Council on Africa
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Did you know that you can contribute to the standards development process? Share your comments on the proposed USP standards below by July 31, 2024. Proposed New Monographs: European Elder Berry Juice Concentrate, European Elder Berry Liquid Extract and Nicotinamide Riboside Chloride Proposed Monograph Revisions: Southern Schisandra Fruit and Southern Schisandra Fruit Powder Submit your feedback today: https://ow.ly/zUoM50RIfiX
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Webinar Announcement: New USP General Chapters <662> and <1662> We are excited to announce an upcoming webinar focused on the new USP General Chapters <662> and <1662>, which cover metal packaging materials and components. This insightful session will provide a comprehensive overview of the rationale behind these chapters, including their development history, purpose, and intent. We invite you to engage in a live Q&A discussion where key highlights will include: • Introduction of the new General Chapter <662> for Metal Packaging Systems, to be published in the Pharmacopeial Forum (PF) in July 2024. • In-depth discussion with USP Senior Principal Scientist Desmond G. Hunt and USP Expert Committee member Dr. Michael Eakins. • Q&A session to address your questions and provide further insights. We would like to encourage everyone to familiarize themselves with the chapter draft in the Pharmacopeial Forum (PF) before the webinar to make the most of the discussion. Register for this event below! https://cvent.me/P2EaPL ⬇
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After 4 years working with USAID's Cure Tuberculosis project, led by JSI to combat #TB in the #KyrgyzRepublic, we reflect on the progress made in pharmacy management, procurement, and quality control, as well as the important work still left to do. Read the blog: https://ow.ly/WHbA50Sx9T7
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Recognized globally for our quality standards, USP's Verification Programs help manufacturers and suppliers not only build quality into their systems, but also maintain it. Watch the video below to learn more about USP's Verification Programs. #USPVerified