Product quality control testing for the oral polio vaccine

Dev Biol Stand. 1998;94:217-9.

Abstract

A brief overview regarding the quality control testing of the Sabin oral polio vaccine is provided. Product testing procedures and specifications are established through product license agreements between the vaccine manufacturer and the FDA Center for Biologics Evaluation and Research. The manufacture and testing of ORIMUNE is a multi-stage process that is closely monitored by the FDA following explicit protocols and requires extensive quality control testing at various stages.

Publication types

  • Review

MeSH terms

  • Animals
  • Cells, Cultured / virology
  • Haplorhini
  • Licensure
  • Poliovirus Vaccine, Oral / standards*
  • Quality Control
  • Simian virus 40 / isolation & purification
  • United States
  • United States Food and Drug Administration
  • Virus Cultivation / standards

Substances

  • Poliovirus Vaccine, Oral