Vaccine safety and quality

Vaccine vials

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 following article provides examples of these procedures and highlights the huge progress accomplished and the remaining challenges in ensuring vaccine safety.

• Dellepiane N, Griffiths E, Milstien JB. New challenges in assuring vaccine quality. WHO Bulletin, 2000, 78: 155-162

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 national regulatory authorities; and
• the WHO vaccine prequalification process

Publications

• Documentation on policy, guidelines and procedures, the Global Training Network, and meetings

WHO activities

• Quality control procedures and quality specifications; NRA assessments; Global Training Network

Page last updated: 14 September 2007