Validation Studies: An Overview of Currently Used Approaches

To provide a safe food supply many factors (materials, processes, people, environment) have to be taken into account and need to be adequately controlled. Systematically, that is addressed by applying HACCP principles throughout the food chain. In that context specific attention has been given to processes in food production controlling hazards. Such processes need to be controllable, reliable and validated. “Validated” thereby referring to Codex Alimentarius: “Obtaining evidence that a control measure or combination of control measures , if properly implemented, is capable of controlling the hazard to a specific outcome.” That purpose can be achieved by different means, where the two main approaches focus on either validation using known scientific, technical, observational information or measuring performance against a desired food safety outcome/target. With respect to process controls for biological hazards and their validation both approaches are used, depending on available knowledge. However, each of them has advantages and disadvantages, which will be discussed during the presentation. Also, elements to be included in a credible validation study, as well as pitfalls to be avoided will be pointed out. Overall, the presentation is aiming to provide the audience with an insight into applicability and uncertainties of validation data and their interpretation.