Organization’s standards enable trust in medicine for more than 200 years
Rockville, Md., October 7, 2022 – U.S. Pharmacopeia (USP) recognizes World Standards Week (October 10-14, 2022) with a focus on the critical role standards play in the global medicines supply chain. Standards help governments and manufacturers increase the availability of safe quality medicines and build patient and health provider trust.
More than 200 years ago, a group of physicians founded USP as one of the nation’s earliest public health initiatives to protect patients from poor quality medicines. Today, USP scientists work with volunteer experts from industry, academia and government to develop quality standards that help ensure a drug ingredient or medicine is exactly what it purports to be and does not contain something it should not, such as adulterants or impurities.
“Our standards and related materials help promote a strong, resilient medicine supply chain – crucial for patients to receive the medicines they need, when they need them,” said Ronald T. Piervincenzi, Ph.D., USP Chief Executive Officer. “USP science-backed standards encourage quality throughout the development and manufacturing process, enabling confidence that the medicines we use are safe and effective.”
USP develops two types of quality standards—documentary and reference. Documentary standards (monographs) cover everything from developing a drug to storing it, and reference standards (physical standards) are highly characterized samples that can be used as benchmarks for evaluating drug ingredients and finished drug products. The USP-NF includes more than 5,000 quality standards for medicines, the most comprehensive source in the world. USP standards are enforceable in the U.S. by the Food and Drug Administration and are legally recognized in more than 50 countries.
USP is applying its knowledge in medicine standards towards creating new solutions to make the supply chain more resilient, including:
- Advanced manufacturing technology – increase overall medicine production capability, expand manufacturing to more regions to reduce over-reliance on sourcing from a few countries and increase the overall quality of medicines and quality control processes
- Medicine Supply Map – early-warning capability for potential disruptions in the upstream medicines supply chain
- Nitrosamines Exchange – open-access platform for manufacturers, scientists and other stakeholders around the world to share real-time updates, learnings, challenges and solutions—including how to mitigate against drug substance-related nitrosamine impurities, or DSRNIs
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide.