Module 3 Presentations

07/05/2024

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

15

Drug Substance Assay Intermediate Precision

• “The applicant should establish the effects of random events on the precision….Typical variations….include days, analysts, equipment…” (Q2(R1) wording). • Historically, a simple matrix of method determination by two different analysts on three days using three different pieces of equipment has appeared globally acceptable. • Japan has higher requirements

The Organisation for Professionals in Regulatory Affairs

16

8