Covers Continued Process Verification (CPV) as the ongoing demonstration that a commercial manufacturing process remains capable and in a state of control. Topics include CPV monitoring, statistical trending, process variability and drift, signal detection, investigations, performance assessment, and the use of manufacturing data to support lifecycle decisions and continued process control.
Continued Process Verification (CPV) is Stage 3 of the process-validation lifecycle and provides ongoing assurance that a commercial manufacturing process remains in a state of control after Process Performance Qualification (PPQ). Unlike PPQ, which evaluates the process during a defined…
Continued Process Verification (CPV) is intended to detect changes in process behavior before those changes develop into product-quality failures or a loss of the validated state. A statistical signal, unusual trend, increasing variability, or unexpected process response should therefore be…
Continued Process Verification (CPV) generates ongoing evidence that a commercial manufacturing process continues to perform as intended. The value of CPV, however, does not come from collecting data or producing statistical charts alone. Process and product information must be periodically…