With the development of new vaccines technologies—for example, mRNA vaccines—regulatory guidelines and industry standards need to evolve. Ensuring the quality of these vaccines and therapies is critical to meeting regulatory requirements, increasing access, and building public trust.
USP collaborates with scientific experts from the academic, industry, healthcare practitioner, and regulatory communities to address quality of these new therapies. USP standards and resources provide manufacturers with analytical methods that support quality throughout the development process. USP also offers regulators and national quality control laboratories benchmarks to ensure vaccine quality remains consistent from manufacturing through administration as they release new vaccines in their countries.
As regulatory guidelines and industry standards for new vaccines and therapies evolve, USP resources can help get products to market faster and ensures patients have access to the medicines that they need when they need them.
USP Standards in Support of the Manufacturing and Distribution of Quality Vaccines
Case Study: USP Supports Health Response to COVID-19 Pandemic
The pandemic caused an unprecedented surge in demand for the development of vaccines that could control the spread of COVID-19 using diverse technologies. To continue to build public trust and confidence in these innovative products we need to ensure they are of good quality, safe and effective.
As new COVID-19 vaccines were developed and distributed, USP made widely available any existing public quality standards that applied to the vaccines in production, providing benchmarks to ensure that medicine quality remained consistent from manufacturing through administration. USP also looked for new ways to create a shared understanding of what quality looked like, with the goals of accelerating product development, guiding successful scale-up of manufacturing and fueling regulatory confidence.