Unit 9: Instrument Qualification and Calibration
This unit explains the lifecycle of instrument qualification (DQ, IQ, OQ, PQ) and calibration requirements in analytical laboratories. It covers regulatory expectations, documentation standards, and performance verification parameters to ensure instruments remain compliant and reliable throughout their use.
Instrument qualification ensures that analytical instruments are installed, operated, and perform according to predefined specifications. The lifecycle includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
| Stage | Purpose |
|---|---|
| DQ | Confirms design meets intended purpose. |
| IQ | Verifies correct installation and documentation. |
| OQ | Tests operational performance under controlled conditions. |
| PQ | Demonstrates consistent performance in routine use. |
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