Module 9 2021

24/03/2021

Before validating an assay I

Development and optimization

•

• Robustness studies (advised, phase dependent) • Characterization/Qualification Studies • Monitoring and trending • Setting acceptance criteria …………… not a linear sequence

The Organisation for Professionals in Regulatory Affairs

45

45

Before validating an assay II

Finalize method protocol

•

Select validation sample(s)

•

Write Validation Protocol

•

GMP QA sign-off

•

The Organisation for Professionals in Regulatory Affairs

46

46

23