Module 3 2019

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.

But …Japan….?

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The Organisation for Professionals in Regulatory Affairs