Monitoring immunization safety
Vaccine safety and quality
An important challenge of immunization safety is to ensure vaccine quality and safety. This must occur from the development stages through clinical trials, vaccine production, quality control and distribution, up to the point of use, where adequate practices for immunization must be in place.
In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure vaccine quality and safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by fully functional national regulatory authorities, demonstration of production consistency and enhanced pre and post-market surveillance for possible adverse events, following the use of these vaccines. These procedures help assure vaccine quality, efficacy and safety.
The WHO Department of Immunization, Vaccines and Biologicals at WHO is actively involved in ensuring vaccine quality in the following ways:
- developing global norms and standards for vaccines
- providing guidelines and support to the national regulatory authorities
- through the WHO vaccine prequalification process
More on vaccine safety quality
- Dellepiane N, Griffiths E, Milstien JB. New challenges in assuring vaccine quality. WHO Bulletin, 2000, 78: 155-162 [pdf 272kb]
- Documentation on policy, guidelines and procedures
- Quality control procedures and quality specifications; NRA assessments; Global Training Network
Last updated: 8 April 2009