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This publication contains the recommendations of a WHO Expert Committee, which met in Geneva in November 2001, relating to quality and standardisation of biological products. Aspects discussed include: the production and quality control of meningococcal group C conjugate vaccines; guidelines for regulatory expectations for clinical evaluation of vaccines; guidelines for the production and quality control of inactivated oral cholera vaccines; guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products; information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances.