Lot release of vaccines by regulatory authorities and harmonization of testing requirements

Abstract

The lot release of vaccines by regulatory authorities is an important component of the regulation and control of vaccines. The process involves an independent evaluation of quality of each lot of a licensed vaccine, including independent testing by regulatory authorities, if necessary, before its release to the market. Lot release is essential to ensure safety and efficacy of vaccines, given to healthy population, due to biological and complex nature of vaccines products. By performing lot release, regulatory agencies provide maximum level of assurance of safety and potency of vaccines. This chapter describes the role and process of lot release of vaccines. Additionally, the chapter discusses about challenges in lot release and harmonization of testing requirements for vaccines.