International Biological Standards and other reference materials make a critically important contribution to the standardisation, quality control and potency estimation of biological medicinal products. Many of these are calibrated in units of biological activity established by consensus following extensive international studies involving many laboratories. There is a hierarchy of standards; World Health organisation and International Biological Standards are the primary standards against which secondary standards are calibrated. Secondary standards may be national standards, regional standards or working reference materials used routinely in the laboratories of manufacturers, Regulatory Authorities or others. In this way the potency of biological medicinal products is calibrated traceable to the WHO primary standard.

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