Module 9 2021

24/03/2021

Measurements in Bioassays

Two tier system Primary Reference and Secondary (working) Ref ICH Q7 Primary Reference • A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be: (1) obtained from an officially recognised source, or (2) prepared by independent synthesis, or (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.

The Organisation for Professionals in Regulatory Affairs

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Measurements in Bioassays

Qualities of a Primary Reference Standard • Integrity of activity • Homogeneity • Stability • Suitability • Sufficient number of aliquots • Continuity

The Organisation for Professionals in Regulatory Affairs

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