The full form of PPQ is Process Performance Qualification.
PPQ is a critical step in process validation, specifically within the Process Qualification stage. It goes beyond initial validation to assess the long-term consistency and robustness of a manufacturing process under normal operating conditions. This involves rigorous testing and monitoring to ensure the process consistently delivers a product that meets predetermined quality attributes.
In simpler terms, PPQ verifies that a manufacturing process not only can work, but reliably does work as intended over time.
Key aspects of Process Performance Qualification include:
- Demonstrating Process Robustness: Ensuring the process can withstand normal variations in raw materials, equipment, and environmental conditions.
- Long-Term Monitoring: Collecting data over an extended period to identify potential trends or deviations.
- Statistical Analysis: Applying statistical methods to analyze process data and confirm process capability.
- Documenting Results: Meticulously documenting all aspects of the PPQ process, including protocols, data, and conclusions.
By successfully completing PPQ, manufacturers can gain confidence in their processes and ensure product quality and consistency.
