Rockville, MD, June 1, 2020 –In a recent publication, U.S. Pharmacopeia (USP) science leaders review the importance of quality standards for the pharmaceutical industry and their impact on manufacturers, regulators, the healthcare industry and public health. Published in The Journal of Pharmaceutical Sciences, USP authors also look at applications for quality standards for complex products such as biologics and biosimilars to maximize the health benefits to patients while minimizing the burden on industry.
Given the increasing complexity of new and emerging therapeutics, the authors of Do Standards Matter? What Is Their Value? consider how best to leverage standards to support these new products during development, regulatory filing and manufacturing. They invite stakeholders from the scientific, healthcare and regulatory communities to contribute to defining standards in a public and transparent way. Only through these combined efforts and expertise will standards continue to minimize barriers to quality medicines.
Learn more about the USP standards development process and how USP standards help ensure the quality of medicines.
About USP
U.S. Pharmacopeia (USP) is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements and food ingredients worldwide. USP’s quality standards are enforceable in the United States by the Food and Drug Administration and integrated into law in more than 40 countries. These standards, which are continuously developed and revised by more than 800 volunteer experts in science, industry, healthcare and academia, are also used in more than 150 countries.