USP Standards in Support of the Manufacturing and Distribution of Quality Vaccines

The issue of substandard and falsified (SF) COVID-19 vaccines will likely remain a global problem for many years to come, as the world continues to work toward immunization of the global population and as boosters are needed to counter variants as they emerge. While the WHO advises that vaccines procured from assured sources should not tested again by receiving countries as they have been tested and released already by NRAs, individual countries or manufacturers may have need to develop their own laboratory capacity for testing of COVID-19 vaccines.

To support laboratories that need to develop and validate assays for assessment of quality attributes of vaccines, USP has created toolkits that can help navigate USP’s documentary standards to support these assessments. These toolkits are organized based on the various COVID-19 vaccine platforms currently in use for authorized COVID-19 vaccines. The Vaccine Quality Attributes Toolkits include common quality tests, standards and other information to support development and validation of analytical tests commonly used to ensure quality of vaccines. These toolkits can help reduce risks from substandard and falsified vaccines, and, ultimately, increase public trust.

About the Quality Assessment Toolkits

  • Informational resource and not meant to imply that all the tests are required
  • Many of the USP resources are informational and not step-by-step methods
  • Follow local laws and cGMPs to determine which tests are required
  • These analytical toolkits focus on final vaccine product (not bulk vaccine substance)
  • Compendial assays (including tests for sterility and endotoxin) are included as a separate Compendial Assay toolkit
  • Toolkits are presented by vaccine manufacturing platform and are not specific to any vaccine product
  • The toolkits do not include assessment of excipients or adjuvants which are important components of some vaccines
  • For some tests, it may be necessary to extract the API to prevent interference

Along with this resource, USP is providing complimentary access to select chapters within the USP United States Pharmacopeia—National Formulary (please see detailed instruction in the toolkit about how to register for your account).

To access the chapters please Register here

Download the Toolkits here: