Equipment Qualification — IQ/OQ/PQ Protocol¶
1. Installation Qualification (IQ)¶
| Requirement | Verification |
|---|---|
| Equipment received undamaged | Visual inspection, photos |
| Manufacturer documentation received | Manuals, drawings, certificates |
| Utilities connected correctly | Electrical, water, gas, exhaust |
| Software installed and version verified | Version number recorded |
| Safety systems functional | E-stop test, alarms |
2. Operational Qualification (OQ)¶
| Test | Acceptance | Documentation |
|---|---|---|
| All modes of operation | Performs per specification | OQ report |
| Alarm functions | Alarms trigger correctly | Calibration certificate |
| Safety interlocks | Function as designed | OQ checklist |
| Software functions | All menus accessible | Printout of screens |
3. Performance Qualification (PQ)¶
| Equipment | PQ Test | Acceptance |
|---|---|---|
| HPLC | System suitability (repeatability, resolution) | USP/EP criteria |
| Balance | Weight accuracy with certified masses | ±0.1% |
| pH meter | Buffer calibration | Slope 95 – 102% |
| Lyophilizer | Empty chamber temperature uniformity | ±1.0 °C |