Definition
Process parameters whose variability can affect a critical quality attribute and therefore require monitoring or control.
Human Explanation
CPP are process settings or conditions that must remain appropriately controlled.
Why it Matters
Uncontrolled CPP can cause the process to produce results that fail quality requirements.
Conceptual Boundary
Not every process parameter is critical; criticality must be supported by knowledge and risk-based evidence.
Practical Perspective
CPP are identified during process design and Risk Management, then connected to suitable controls and monitoring.