Vaccine Standards

Substandard and falsified vaccines put individuals at risk of contracting preventable diseases and erode public trust in vaccines and the healthcare system. Vaccine manufacturers, regulators and law enforcement need quality control tools that help keep these dangerous and sometimes deadly products off the market. USP recognizes this need and provides resources that support the high-quality manufacturing, packaging, and release processes of vaccines. These resources help to address broader challenges associated with vaccine distribution and administration, which further contribute to public confidence in vaccination efforts.

What's New

mRNA Vaccine Chapter Header

Analytical Procedures for mRNA Vaccine Quality

Viral Vector

Analytical Procedures for Viral Vectored Vaccine Quality

Vaccine image

Vaccine Quality Assessment Toolkits

Resources


Reference Standard

PS NMR System Suitability

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Analytical Reference Materials

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Documentary Standards

  • <1234> Vaccines for Human Use – Polysaccharides & Glycoconjugate Vaccines
  • <198> Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Polysaccharides Used in Vaccine Manufacture
  • <1239> Vaccines for Human Use – Viral Vaccines
  • <1235> Vaccines for Human Use – General Considerations
  • <1238> Vaccines for Human Use – Bacterial Vaccines

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Education

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