Documentation centre

WHO Guidelines and Recommendations - Technical Report Series

• Regulation and licensing of biological products in countries with newly developing Regulatory Authorities; Technical Report Series (TRS) No 858, Annex 1 (Adopted by ECBS 1994)
  pdf, 773kb
• WHO Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. Technical Report Series (TRS) No 814, Annex 3 (Adopted by ECBS 1990)
  pdf, 659kb
• WHO Guidelines for national authorities on quality assurance for biological products. TRS No 822, Annex 2 (Adopted by ECBS 1991)
  pdf, 789kb
• WHO Guidelines for the Preparation, Characterization and Establishment of International and Other Biological Reference Standards. WHO Technical Report Series (TRS) No (in press) (Adopted by ECBS 2004)
  pdf, 441kb
• 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
• WHO Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO Technical Report Series (TRS) No. 924, Annex 4 (Adopted by ECBS 2001)
  pdf, 630kb
• WHO Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives. WHO Technical Report Series No. 840, Annex 2 (Adopted by ECBS 1992)
  pdf, 3.27Mb
• WHO Recommendations for the Production, Control and Regulation of Human Plasma for Fractionation. ECBS 2005. WHO/BS/05.2019
  pdf, 372kb
• WHO Guidelines on Transmissible Spongiform Encephalopathies in Relation to Biological and Pharmaceutical Products. ECBS 2003
  pdf, 123kb
• Technical report series (TRS): complete list (chronological order)
  

WHO International Reference Materials for IN Vitro Diagnostic Devices: Reports and Collaborative Studies

• Report of the WHO Consultation on Global Measurement Standards and their use in the in vitro Biological Diagnostic Field (Jun 2004)
  pdf, 69kb
• Report of the WHO Consultation on International Biological Standards for in vitro Diagnostic Procedures based on Nucleic Acid Amplification Techniques (NAT). Geneva, Switzerland (Apr 2002)
  pdf, 72kb
• Report of the WHO Consultation on International Biological Standards for in vitro Diagnostic Procedures. Geneva, Switzerland (Sep 2000)
  pdf, 127kb

Infectious markers

• Report of the WHO Working Group on International Reference Preparations for Testing Diagnostic Kits used in the Detection of HBsAg and anti-HCV Antibodies (Oct 2003)
  pdf, 60kb
• Report of the WHO Working Group on Reference Preparations for Testing Diagnostic Kits used for Detection of HBsAg, Anti-HCV and Anti HIV antibodies in blood screening. Geneva, Switzerland (Jan 2000)
  pdf, 60kb

Hepatitis B markers:

• Principles in Evaluation of HBsAg Test Kits: Appropriate Use of 2nd WHO International Standard (IS) and Reference Panel for HBsAg (WHO, Geneva, Nov 2004)
  pdf, 24kb
• Hepatitis B surface antigen, subtype adw2, genotype A. 2nd International Standard and Reference Panel. ECBS 2003. Collaborative Study: WHO/BS/03.1987
  pdf, 1.05Mb
• Hepatitis B virus DNA. 1st International Standard. ECBS 1999. Collaborative Study: WHO/BS/99.1917
  pdf, 2.61Mb
• Anti-hepatitis B immunoglobulin, human. 1st International Reference Preparation. ECBS 1977. Collaborative Study: WHO/BS/77.1164
  pdf, 1.83Mb

Hepatitis C markers:

• Hepatitis C virus RNA. 2nd International Standard. ECBS 2003. Collaborative Study: WHO/BS/03.1958
  pdf, 47kb

HIV markers:

• HIV-1 RNA. 2nd International Standard. ECBS 2005. Collaborative Study: WHO/BS/05.2021
  pdf, 142kb
• HIV-1 RNA genotypes (set of 10 genotypes). 1st International Reference Panel. ECBS 2003. Collaborative Study: WHO/BS/03.1961
  pdf, 78kb
• HIV-1 p24 antigen. Collaborative Study: 1st International Standard. ECBS 1992. WHO/BS/92.1699
  pdf, 2.06Mb

HAV markers:

• Hepatitis A RNA. 1st International Standard. ECBS 2003. Collaborative Study: WHO/BS/03.1959
  pdf, 334kb

Parvovirus B19 markers:

• Parvovirus B19 DNA human. 1st International Standard. ECBS 2000. Collaborative Study: WHO/BS/00.1928
  pdf, 3.68Mb

Blood grouping reagents

• Report on the Review and Update of the WHO International Standards for Blood Grouping Reagents. Amsterdam, The Netherlands (Oct 1999)
  pdf, 56kb
• Review and replacement of International Standard for blood-grouping reagents: WHO Expert Committee on Biological Standardization (ECBS 1998), Technical Report Series (TRS) No 897, p. 17, 49th report. Geneva, Switzerland (2000)
  pdf, 4.83Mb
• International Standard for minimum potency of Anti-A and Anti-B Blood grouping reagent. 1st International Standard: ECBS 2006. Collaborative Study: WHO/BS/06.2053
  pdf, 624kb
• Anti-A blood grouping serum, human. 2nd International Standard. ECBS 1981. Collaborative Study: WHO/BS/81.1309
  pdf, 6.57Mb
• International Standard for minimum potency of Anti-A and Anti-B blood-grouping reagents. 1st International Standard. ECBS 2006. Collaborative Study: WHO/BS/06.2053
  pdf, 624kb
• Anti-B blood-grouping serum, human. 3rd International Standard. ECBS 1981. Collaborative Study: WHO/BS/81.1309
  pdf, 6.57Mb
• Anti-C complete blood-grouping serum, human. 1st International Standard. ECBS 1984. Collaborative Study: WHO/BS/83.1424
  pdf, 1.25Mb
• Anti-C incomplete blood-grouping serum, human. 1st International Standard. ECBS 1976. Collaborative Study: WHO/BS/71.1038
  pdf, 210kb
• Anti-D (Anti-RhO) complete blood-grouping serum, mouse monoclonal. 1st International Standard for Minimum Potency of Anti-D Blood-grouping Reagents. ECBS 2004. Collaborative Study: WHO/BS/04.2000 Rev.1
  pdf, 121kb
• Anti-D (anti-Rh0) incomplete blood-grouping serum, human, 1st International Standard. ECBS 1966. Collaborative Study: WHO/BS/66.810
  pdf, 3.57Mb
• Anti-E complete blood-grouping serum, human. 1st International Standard. ECBS 1984. Collaborative Study: WHO/BS/83.1424
  pdf, 1.25Mb

Transmissible spongiform encephalopathies (TSE)

• WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies 2006
  pdf, 638kb
• WHO Guidelines on Transmissible Spongiform Encephalopathies in Relation to Biological and Pharmaceutical Products (Adopted by ECBS 2003)
  pdf, 123kb
• WHO manual for surveillance of human transmissible spongiform encephalopathies including variant Creutzfeldt-Jakob disease, Geneva, Switzerland (2003)
  pdf, 638kb
• Report on International Reference Materials for Diagnosis and Study of Transmissible Spongiform Encephalopathies (TSEs). Working group fourth meeting, Geneva, Switzerland (April 2002)
  pdf, 99kb
• Report on International Reference Materials for Diagnosis and Study of Transmissible Spongiform Encephalopathies (TSEs). Working group third meeting, Geneva, Switzerland (March 2001)
  pdf, 81kb
• Report on International Reference Materials for Diagnosis and Study of Transmissible Spongiform Encephalopathies (TSEs). Working group second meeting, Geneva, Switzerland (May 2000)
  pdf, 86kb
• Report on International Reference Materials for Diagnosis and Study of Transmissible Spongiform Encephalopathies (TSEs). Working group first meeting, Geneva, Switzerland (Sep 1999)
  pdf, 62kb
• Report on WHO Consultation on Diagnostic Procedures for Transmissible Spongiform Encephalopathies (TSEs): Need for Reference Reagents and Reference Panels. Geneva, Switzerland (March 1999)
  pdf, 77kb

Creutzfeldt-Jakob Disease reagents

• WHO Reference Reagents for In Vitro Assays of CJD Specimens. ECBS 2003. Collaborative Study: WHO/BS/03.1965 Rev.1
  pdf, 127kb

Blood coagulation disorders

Blood coagulation factors:

• Press release
  pdf, 21kb
• Blood coagulation factor V Leiden, human gDNA. 1st International Genetic Reference Panel. ECBS 2004. Collaborative Study: WHO/BS/04.1997
  pdf, 102kb
• Blood coagulation factor XIII, plasma, human. 1st International Standard. ECBS 2004. Collaborative Study: WHO/BS/04.1994 Rev.1
  pdf, 187kb
• Blood coagulation factor VIII and von Willebrand factor, plasma, human. 5th International Standard. ECBS 2003. Collaborative Study: WHO/BS/03.1972
  pdf, 1.41Mb
• Blood coagulation factors II, VII, IX, X, plasma, human. 3rd International Standard. ECBS 2001. Collaborative Study: WHO/BS/01.1946
  pdf, 8.05Mb
• Blood coagulation factor V in plasma, human, 1st International Standard, ECBS 2005, Collaborative Study: WHO/BS/05.2007
  pdf, 176kb
• Blood coagulation factor XI in plasma, human, 1st International Standard, ECBS 2005. Collaborative Study: WHO/BS/05.2017
  pdf, 219kb
• Prothrombin Mutation, Human gDNA. 1st International Genetic Reference Panel. ECBS 2005. Collaborative Study: WHO/BS/05.2022
  pdf, 336kb

Thromboplastin reagents:

• Thromboplastin, rabbit, plain. 4th International Standard. ECBS 2005. Collaborative Study: WHO/BS/05.2029
  pdf, 151kb
• Thromboplastin, human, recombinant, plain. 3rd International Reference Preparation. ECBS 1996. Collaborative Study: WHO/BS/96.1846 Rev.1
  pdf, 6.94Mb
• Thromboplastin, bovine, combined. 2nd International Reference Preparation. ECBS 1983. Collaborative Study: WHO/BS/83.1393
  pdf, 672kb

Inhibitors:

• Protein S, plasma, human. 1st International Standard. ECBS 1995. Collaborative Study: WHO/BS/95.1804
  pdf, 4.72Mb
• Protein C, plasma, human. 1st International Standard. ECBS 1987. Collaborative Study: WHO/BS/87.1561
  pdf, 671kb

Others:

• 2nd IS Vitamin B12 and 1st IS Serum Folate. ECBS 2006. Collaborative Study: WHO/BS/06.2052
  pdf, 368kb

ANIMAL (ANTIVENOM) SERA

• Assessment of the viral safety of antivenoms fractionated from equine plasma. Th. Burnouf, E. Griffiths, A. Padilla, S. Seddik, M.A. Stephano, J.-M. Gutiérrez. Biologicals 32, p. 115-128 (2004).
  pdf, 229kb
• Report of a WHO workshop on the standardization and control of antivenoms. Theakston RD, Warrell DA, Griffith E. Toxicon 41 (5) 541-57 (2003)
  pdf, 207kb
• Note for Guidance on Production and Quality Control of Animal Immunoglobulins and Immunosera for Human Use (EMEA 2002)
  pdf, 208kb
• Snake-bites: appraisal of the global situation. Chippaux, J. P. WHO Bulletin 76 (5) 515-524 (1998)
  pdf, 456kb

STRENGTHENING NATIONAL REGULATORY SYSTEMS

• Ensuring the Quality and Safety of Plasma Derived Medicinal Products, Information Sheet
  pdf, 54kb
• PIC/S GMP Guide for Blood Establishments (Jul 2004)
  pdf, 209kb
• Plasma Contract Fractionation Program, Information Sheet
  pdf, 106kb
• Quality and safety of blood products and related substance, AIDE-MEMOIRE, WHO
  pdf, 95kb
• Strengthening National Regulatory Authorities, AIDE-MEMOIRE, WHO (May 2003)
  pdf, 722kb
• WHO Workshops

INTERNATIONAL CONFERENCE OF DRUG REGULATORY AUTHORITIES (ICDRA) - WORKSHOPS ON BLOOD PRODUCTS

• Eleventh International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Assuring quality and safety of blood products. Madrid, Spain (2004)
• Tenth International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Safety of blood-derived products. Hong Kong, China (2002)
• Ninth International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Safety issues of plasma-derived medicinal products. Berlin, Germany (1999)

• Meeting on Development of Harmonization of QA system for Blood Products in Asian Countries, SEARO (2004)
• WHO Regional Workshop on Good Manufacturing Practices for Blood/Plasma Collection Establishments, AMRO/PAHO (2004)
• WHO Workshops
• WHO Regional Consultation for Quality Assurance, and Safety of Plasma and Plasma Derivatives, EMRO (2005)
• WHO Regional Workshop on Quality Assurance and Safety of Plasma Derivatives, AMRO (2001)