Hi Dr. Simon!

The heart of validating a process is ensuring it is installed to specification, while characterized and optimized to be under control and capable of consistently meeting specifications. I believe that both the FDA and ISO still require “full” verification for a process that supposedly did not need validation. While the wording of the requirements differs between FDA and ISO, the intent is the same when it comes to the validation of a product. However, it seems like ISO is less strict when it comes to following the requirements. According to the FDA requirement, if the results cannot be fully verified after following inspection and test, the process must be validated, approved, and documented by those who approved the validation. On the other hand, according to the ISO requireent, validation needs to occur when the resulting output cannot be verified after monitoring or measurement. The company is allowed to come up with the best method of validation, and if they do so, then they do not have to complete a “full” validation.