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.
Resources
Education
- An Introduction to USP’s COVID-19 Vaccine Quality Assessment Toolkits (On-Demand)
- COVID 19 Vaccine Distribution and Storage: Increasing Access to Quality, Safe, and Effective Vaccine Products (On-Demand)
- Introduction to GMP Manufacturing and Characterization of Vaccines for Human Use (On-Demand)
- Cell Banking for Manufacturing of Vaccines (On-Demand)
- Production of Vaccines and Sterile Biologics (On-Demand)
- Quality Control of Vaccines Manufacturing (On-Demand)
- Regulatory and WHO Prequalification Considerations for Vaccines (On-Demand)
- What’s New in Biologics Focus on USP’s Vaccine Initiatives (On-Demand)
- Bringing COVID-19 Vaccines and Therapeutics to the Global Community (On-Demand)
- Implementing Improved Analytical Methods to Support Vaccine Quality (On-Demand)
- What’s New in Biologics? Focus on USP’s COVID-19 Response (On-Demand)
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Reference Standard
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Analytical Reference Materials
BHK-21, MDCK, MRC-5, and Vero Genomic DNA Analytical Reference Materials
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Documentary Standards
- <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
- Draft Guidelines – Analytical Procedures for mRNA Vaccine Quality
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