Process Validation
Quality
Process Validation
Documented evidence that a process consistently produces output meeting predetermined requirements.
Examples
- 01Before the new sterile filling line goes live, process validation shows that three consecutive batches meet fill volume, sterility and particle limits.
- 02The auditor reviews the process validation report and asks why worst-case conditions, such as maximum line speed, were not included.
- 03After the filling needles are replaced by a different design, process validation is repeated before any product is released.