WHO Drug Information Vol. 17, No. 1, 2003
(2003; 77 pages) View the PDF document
Table of Contents
Open this folder and view contentsReports on Individual Drugs
Close this folderVaccines and Biomedicines
Close this folderQuality assurance and safety of biologicals
View the documentProduction and quality control recommendations
View the documentVaccines
View the documentBlood products
View the documentInternational Reference Materials
Open this folder and view contentsCurrent Topics
Open this folder and view contentsSafety Issues
Open this folder and view contentsEssential Medicines
Open this folder and view contentsRegulatory and Safety Action
Open this folder and view contentsRecent Publications and Sources of Information
View the documentProposed International Nonproprietary Names: List 88
View the documentAnnex 1 - PROCEDURE FOR THE SELECTION OF RECOMMENDED INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES*
View the documentAnnex 2 - GENERAL PRINCIPLES FOR GUIDANCE IN DEVISING INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES*
View the documentAnnexe 1 - PROCEDURE A SUIVRE EN VUE DU CHOIX DE DENOMINATIONS COMMUNES INTERNATIONALES RECOMMANDEES POUR LES SUBSTANCES PHARMACEUTIQUES
View the documentAnnexe 2 - DIRECTIVES GENERALES POUR LA FORMATION DE DENOMINATIONS COMMUNES INTERNATIONALES APPLICABLES AUX SUBSTANCES PHARMACEUTIQUES*
View the documentAnexo 1 - PROCEDIMIENTO DE SELECCION DE DENOMINACIONES COMUNES INTERNACIONALES RECOMENDADAS PARA LAS SUSTANCIAS FARMACEUTICAS
View the documentAnexo 2 - PRINCIPIOS GENERALES DE ORIENTACION PARA FORMAR DENOMINACIONES COMUNES INTERNACIONALES PARA SUSTANCIAS FARMACEUTICAS*
 

Quality assurance and safety of biologicals

In order to assure the quality and safety of biological medicines and in vitro diagnostic procedures, the WHO Expert Committee on Biological Standardization provides guidance and technical specifications through the establishment of international reference preparations and recommendations for the production and control of biological products. The following summary sets out the decisions made by the Expert Committee at its recent meeting in Geneva*. A detailed report will be published in the WHO Technical Report Series. Information is also available on http://www.who.int/biologicals.

*Fifty-third meeting of the WHO Expert Committee on Biological Standardization, 17-21 February 2003, Geneva. Participation included members from: Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Republic of Korea, Mexico, Netherlands, Russian Federation, Switzerland, United Kingdom, United States of America. Representatives from: Global Collaboration of Blood Safety, European Diagnositic Manufacturers Association, Council of Europe, European Plasma Fractionation Association, International Association of Biologicals, International Bureau of Weights and Measures, International Federation of Clinical Chemistry and Laboratory Medicine, International Federation of Pharmaceutical Manufacturers Associations, International Sociaety on Thrombosis and Haemostatis, Plasma Protein Therapeutics Association, United States Pharmacopeia.

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Last updated: May 3, 2013