WHO Expert Committee on Biological Standardization. Forty-ninth report.
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international requirements for the production and quality control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the Committee's attention and provides information on the status and development of reference materials for various antibodies, antigens, blood products, cytokines, and toxins. The second part of the report, of particular interest to manufacturers and national control authorities, contains two specific sets of requirements: for Haemophilus influenzae type b conjugate vaccines and for oral poliomyelitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine, and other relevant documents.
D001688:Biological Products / Q000592:standards* / Q000600:supply & distribution; D004345:Drug Industry / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D011786:Quality Control; D012015:Reference Standards; D014944:World Health Organization
D001688:Biological Products