Vaccine Safety and Quality - WHO activities
Quality control procedures and quality specifications
The WHO Expert Committee on Biological Strandardization (ECBS) plays a key role in overseeing scientific progress and in establishing international reference material and recommendations on the production and control of biological products.
Guidelines and recommendations adopted by the ECBS in 2004 related to :
- the production and quality control of candidate tetravalent dengue virus vaccines (live); and
- and the preparation, characterization and establishment of international and other biological reference standards.
A list of international standards and reference reagents for biological substances was issued in WHO Technical Report Series, 897, 2000 (Annex 5).
The ECBS made changes to the previous list. An updated version is provided in WHO Technical Report Series, 926, 2004 (Annex 5).
Copies of the list may also be obtained from appointed sales agents for WHO publications or from: Distribution and Sales, World Health Organization, 1211 Geneva 27, Switzerland
Guidelines have, during the last few years, been written on: clinical evaluation of vaccines; regulatory expectations; inactivated oral cholera vaccines; inactivated poliomyelitis vaccine; and thiomersal. Guidelines on non-clinical evaluation of vaccines are currently being published.
Another area of recent work is a revision to the recommendations for the production and quality control of smallpox vaccine.