Biologicals

This web site provides information on WHO norms and standards for the production and control of biological medicines and related in vitro diagnostic tests.

Issues & challenges

Vaccine vials (IVB)

Biological medicines such as blood products, vaccines, cell regulators and related in vitro diagnostic tests are life-saving components of every day medical practice worldwide. The quality assurance of such essential biopharmaceutical products and devices raises however particular safety considerations due to the biological nature of the starting materials used, the manufacturing process involved and the tests methods needed to characterize the production consistency. The increasing complexity and sophistication of biological products and technologies and the rapid growth in this field, present an additional considerable challenge for medicines and medical devices regulatory authorities as well as for manufacturers.

WHO norms & standards

WHO has played a key role for over 50 years in establishing the WHO International Biological Reference Preparations and in developing WHO guidelines and recommendations on the production and control of biological products and technologies. These norms and standards are based on wide scientific consultation and on international consensus and are intended to assist WHO Member States in ensuring the consistent quality and safety of biological medicines and related in vitro biological diagnostic tests worldwide. The Organization develops this work through its biological programme and the WHO Expert Committee on Biological Standardization. This also involves close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers and expert laboratories worldwide.

Call for contribution of HPV Type 16 & Type 18 L1 virus-Like particles
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Call for contribution of human serum ref samples for HPV serology
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The 2nd edition of HPV LabNet newsletter, May 2008
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Call for participation! Proficiency study for evaluating HPV DNA testing capacity (2nd)
Advert and application form

Executive Summary-WHO/Health Canada Consultation on Serological Criteria for Evaluation & Licensing of New Pneumococcal Vaccines
Ottawa, Canada, 7-8 July 2008
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WHO Informal Consultation of the minimum potency specification for yellow fever vaccines
NIBSC, Potters Bar, UK, 19-20 November 2007
Download [pdf 134kb]

WHO Mtg on the standardization of HPV assays and role of WHO HPV LabNet in supporting vaccine introduction,
WHO, Geneva, Switzerland 23-25 January 2008
Download [pdf 371kb]

World Health Organization
Quality, Safety and Standards (QSS)
FCH/IVB/QSS
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Switzerland
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