Module 9 2024

03/09/2024

Assay Design & Stats Analysis

Is the assay valid?

Assay Acceptance Criteria (AAC) • Parameters of the assay used to determine if the Reference material is performing in the expected manner

AAC

The Organisation for Professionals in Regulatory Affairs

29

29

Assay Design & Stats Analysis

Is the assay valid?

Assay Acceptance Criteria (AAC) • Parameters of the assay used to determine if the Reference material is performing in expected manner

AAC

fail

• The assay has failed • Do not process the sample data

The Organisation for Professionals in Regulatory Affairs

30

30

15