Module 3 2019

Drug Substance Assay Precision

Repeatability

● “The precision under the same operating conditions over a short interval of time”

● Intra-assay precision – may be assessed with 9 determinations (3 concentrations/3 replicates each), or a minimum of 6 determinations at 100% test concentration

Intermediate Precision

● “Expresses within-laboratories variations: different days, different equipment, etc.”

Reproducibility

● “Expressed the precision between laboratories”

● Not needed for marketing authorization dossiers

● Elements of repeatability are covered during transfer of methods between research and manufacturing sites and also through transfer to Contract Research Organisations

The Organisation for Professionals in Regulatory Affairs