On the one hand several countries validate their processes, on the other hand we still expect them to fail and ask for process controls. Besides daily Bowie Dick tests it seems to be very unclear how many controls we need. In the industrial interpretation, the meaning of a validated process you can only get good parts out of it as long as it is kept within the validation parameters.

If you get failures you need to re-validate potentially with more parameters. This is clearly not how reprocessing should work. Maybe we should start talking about process testing instead of validation.