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Medicines & Healthcare products Regulatory Agency
The National Institute for Biological Standards and Control

Confidence in biological medicines

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Working standards

World Health Organisation international standards are the primary standards for an analyte. They should not be used in routine assays. They are supplied as primary standards which can be used to calibrate secondary standards.

These 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 and traceable to the WHO primary standard.

For some frequently used standards, ‘working standards’ have been prepared at NIBSC which can be supplied in greater quantities, typically in multiples of 5. These are intended for use as direct in-house reference materials.

Working standards are mainly blood product and transfusion reference materials . There are currently over 10 working standards available.

NIBSC working standards

Other standards

NIBSC supplies a range of other non-WHO standards that have been developed over the years.  These include toxoids and anti-sera for bacterial infections, endocrine reference materials, and immunoglobulins. They may be used as direct in-house reference materials.

There are currently over 200 other non-WHO standards available.

 
 
 
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