The fundamental difference between PPQ (Process Performance Qualification) and PQ (Performance Qualification) lies in their scope: PQ focuses on verifying the performance of individual equipment or systems, while PPQ assesses the entire manufacturing process, encompassing equipment, personnel, materials, and the environment.
Here's a more detailed breakdown:
Performance Qualification (PQ)
- Focus: Individual equipment or systems. PQ verifies that a piece of equipment consistently performs according to its intended design specifications under normal operating conditions.
- Objective: To demonstrate and document that equipment, systems, and utilities are properly installed, operate in accordance with their intended use, and perform consistently according to established acceptance criteria.
- Activities: PQ often involves testing the equipment's functionality, accuracy, and reliability. Examples include temperature mapping of a refrigerator, verifying the accuracy of a weighing scale, or testing the speed and fill volume of a filling machine.
- Timing: PQ typically follows Installation Qualification (IQ) and Operational Qualification (OQ) and occurs before the equipment is used in routine manufacturing.
Process Performance Qualification (PPQ)
- Focus: The entire manufacturing process. PPQ confirms that the established manufacturing process, when operated within its validated parameters, consistently produces a product that meets pre-determined quality attributes.
- Objective: To provide documented evidence that the manufacturing process is capable of consistently delivering product meeting its critical quality attributes (CQAs). This includes consideration of raw material variability, equipment capabilities, personnel training, and environmental factors.
- Activities: PPQ involves running multiple production batches, collecting data on critical process parameters (CPPs) and CQAs, and statistically analyzing the data to demonstrate process robustness and capability. Examples include monitoring temperature, pressure, mixing times, and analyzing the final product for purity, potency, and stability.
- Timing: PPQ occurs after the individual equipment and systems have been qualified (IQ, OQ, and PQ) and before commercial production begins. It is a crucial step in process validation.
Key Differences Summarized:
| Feature | Performance Qualification (PQ) | Process Performance Qualification (PPQ) |
|---|---|---|
| Scope | Individual equipment or systems | Entire manufacturing process |
| Objective | Verify equipment performance meets specifications | Verify process consistently delivers quality product |
| Focus | Equipment functionality, accuracy, reliability | Process robustness, capability, control of variability |
| Timing | After IQ/OQ, before routine manufacturing | After PQ, before commercial production |
| Examples | Temperature mapping, scale accuracy testing | Running production batches, analyzing CQAs, statistical analysis |
In essence, PQ ensures the individual components work as intended, while PPQ ensures the entire process, using those components, consistently produces a quality product. Think of PQ as verifying each ingredient is good, and PPQ as verifying the recipe using those ingredients consistently produces a delicious cake.
