Norms and standards
WHO has played a key role for over 50 years in establishing the WHO International Biological Reference Materials and in developing Norms and Standards (WHO Guidelines and Recommendations) on the production and control of biological products and technologies.
The Norms and Standards are developed by the biological program and the WHO Expert Committee on Biological Standardization (ECBS) in close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers and expert laboratories worldwide. Their establishment is therefore based on international consensus resulting from wide scientific consultation.
The Norms and Standards are intended to assist WHO Member States in ensuring consistent quality and safety of biological medicines and related in vitro biological diagnostic tests worldwide.
Related documents
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Recommendations for the preparation, characterization and establishment of international and other biological reference standards (revised 2004) - WHO Technical Report Series No. 932, 2006
pdf, 334kb -
WHO Guidelines on Tissue Infectivity Distribution in TSEs 2006
pdf, 638kb -
WHO Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. Technical Report Series (TRS) No. 924, Annex 4 (Adopted by ECBS 2001)
pdf, 630kb -
WHO Guidelines for Thromboplastins and Plasma Used to Control Anticoagulant Therapy, WHO Technical Report Series No 889, Annex 3 (Adopted by ECBS 1997)
pdf, 1.32Mb -
Regulation and licensing of biological products in countries with newly developing Regulatory Authorities. TRS No 858, Annex 1 (Adopted by the ECBS 1994)
pdf, 773kb -
WHO Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives. TRS No 840, Annex 2 (Adopted by the ECBS 1992)
pdf, 3.27Mb -
WHO Guidelines for national authorities on quality assurance for biological products. TRS No 822, Annex 2 (Adopted by the ECBS 1991)
pdf, 789kb -
WHO Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. TRS No 814, Annex 3 (Adopted by the ECBS 1990)
pdf, 659kb
