AOAC SPADA Meeting

Bacterial Verification Kata lin K i s s, PhD, PMP® S en io r Manager, Manufa c turing S c i enc e and Te c hnology

Bacterial Verification What is the difference between Verification, Validation, Characterization &Authentication ?

Verification should answer the question: does this meet the design specifications?  Bacterial verification‐ does the bacteria in your hands meet the specification of the genus/species/strain?

Validation should answer the question: does this meet the operational requirements of the user? 

Characterization does not answer a question‐ but is a description of the distinctive features of an agent. For example‐ testing for motility, hemolysis, resistance profiles, colony shape and color

Authentication should answer the question: is the verification process acceptable?