Exception

An unexpected result or event during validation

An unexpected result/event, deviation from validation protocol or executable record instructions, or failure to meet process validation protocol acceptance criteria (i.e., expected results) during execution of a validation protocol. Exceptions are specific to excursions from validation protocol testing and procedures, and failures to meet acceptance criteria defined within validation protocols. Exceptions to validation protocols and deviations are separate quality items that should be completed as such based on the applicable quality system being applied. An exception to a validation protocol does not necessarily indicate that a deviation has occurred.