Validation of a critical or precision cleaning process is a good idea whether or not there are specific regulatory requirements to do so. A validated cleaning and contamination control process is important in placing you above the competition.
Consider yourself to be your own customer. A validated method provides an updated benchmark, a statement that says, “here is how the process works, and here is the measure of how well it works.” Any material or process changes that occur subsequently can be compared to this benchmark.
