Module 9 2021

24/03/2021

Assay design & stats analysis

Is the assay valid? Assay Acceptance Criteria (AAC)/ System Suitability Criteria (SSC) • 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

39

39

Assay design & stats analysis

Is the assay valid? Assay Acceptance Criteria (AAC)/ System Suitability Criteria (SSC) • If on other hand

AAC

The Organisation for Professionals in Regulatory Affairs

40

40

20