The Lifecycle Approach to Process Validation: Overview
Tuesday, 11 October 2022
The current view of the world’s regulatory authorities is that Process Validation (PV) demonstrates the adequacy and robustness of the manufacturing control strategy and gives continuing assurance that the process is under control. It is defined in the November 2016 EMA Guideline on process validation as: “Process validation should not be viewed as a one-off
- Published in blog