Testing and compliance to the standards detailed within compendial methods is a basic requirement for manufacturing release and distribution of vaccines and medicinal treatments around the world.
USP public quality standards are a transparent set of tests to show what good looks like developed through a collaborative process between USP, manufacturers and expert committees made up of volunteers from industry, health care practitioners, academia and government. These standards are used in more than 150 countries and integrated into laws of over 40 governments, including in the United States.
USP compendial tests and methods address common issues shared by all drug manufacturers, such as suitability, validation, contamination control, stability testing and qualification of raw materials.
Small to mid-sized organizations, including biotech, university and government labs, to large manufacturers of biopharmaceuticals, can utilize USP’s expertise as they work quickly to develop and obtain regulatory approval.
- Read our regular updates to the USP Quality Matters blog, including the following posts:
- The Role of Standards in Supporting Quality Vaccines Manufacturing and Distribution by John Kokai-Kun, Ph.D., Director, External Scientific Collaboration-Biologics
- Accelerating Development and Building Trust in COVID-19 Vaccines With Public Quality Standards by Jaap Venema, Ph.D., USP Chief Science Officer
- Glycosylation in monoclonal antibody treatments for COVID-19 by Tim Guo, USP Scientist and Annu Uppal, USP Senior Scientific Affairs Manager
- Quality standards for efficiency in drug development and manufacturing by Fouad Atouf, Ph.D., Vice President, Global Biologics