In GDP, what is the difference between “Validation” and “Qualification”? Which systems or equipment require them?

“Qualification” and “validation” both demonstrate that a system, equipment or process can consistently achieve its intended results, but they have different emphases. “Qualification” is usually applied to equipment, facilities and systems. It demonstrates that the “hardware” itself has been installed correctly, operates correctly and is suitable for its intended use. It usually comprises four stages: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Qualification of a new refrigerator is one example. “Validation” focuses more on the “process”: it demonstrates that a complete process or method can consistently produce results that meet predetermined standards. Examples include transport validation of a cold-chain packaging solution and validation of a computerised system. In short, qualification is the foundation for validation: equipment is usually qualified first, followed by validation of the processes that use it.