WHO manual for the establishment of national and other secondary standards for vaccines
Aimed primarily at staff of national control laboratories and vaccine manufacturers, this document contains guidance on the principles of the preparation of national or other secondary biological standards, and details the issues which should be considered in the preparation and calibration of such standards.
National and other secondary biological standards are those which are developed by regional or national regulatory authorities, or by other organizations, and are calibrated against WHO's international biological standards. Such standards are produced in order that national regulatory authorities and other organisations have calibrated and accredited material which can be used in quality control and other product development activities.
While this document relates primarily to national and other secondary standards for the potency testing of vaccines, many of the principles considered also apply to antisera or other biologicals.
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