🔍 Parameters to be Tested at Each Stage of Equipment Qualification
🔍 Parameters to be Tested at Each Stage:
✅ 1. Design Qualification (DQ)
| Parameter | Purpose |
|---|---|
| User Requirement Specification (URS) | Confirms equipment features match user needs |
| Functional Design Specification (FDS) | Confirms controls, alarms, safety features are defined |
| Equipment layout and material of construction | Ensures GMP compliance (e.g., SS 316L) |
| Utility requirements (power, air, water) | Ensure compatibility with facility |
| Risk Assessment (FMEA, HAZOP) | Identifies risks and mitigation at design level |
| Vendor selection and compliance | Confirm vendor is qualified and audited |
| Compliance with GMP, 21 CFR Part 11 (if software used) | Ensures regulatory readiness |
✅ 2. Installation Qualification (IQ)
| Parameter | Purpose |
|---|---|
| Equipment checklist (as per P&ID, drawings) | Confirms all components are installed correctly |
| Verification of nameplate data | Confirms make, model, serial number |
| Calibration status of instruments | Ensure critical sensors/meters are calibrated |
| Utility connection verification | Proper connection of water, air, electricity |
| Material of construction (MOC) certificates | GMP compliance (SS 304/316 etc.) |
| Safety interlocks and grounding | Operational safety confirmation |
| Component identification (labels, tags) | Ensure traceability |
| Document verification (manuals, drawings) | For reference and SOPs |
| Software Installation & Access Controls | For automated systems (Audit Trail, log-in levels) |
✅ 3. Operational Qualification (OQ)
| Parameter | Purpose |
|---|---|
| Verification of functional operation | All buttons, alarms, and modes work as expected |
| Calibration checks (sensors, gauges) | Confirm operation within tolerance |
| Temperature mapping (if applicable) | Ensures uniformity across chambers (e.g., oven, autoclave) |
| Pressure/vacuum hold test (if applicable) | Confirms system integrity |
| Alarm and interlock testing | Safety and control system validation |
| Operational range testing (min, max) | Test from lower to upper set points |
| SCADA / HMI performance | Software interface responsiveness |
| Power failure / restart check | Ensures equipment resumes or alerts properly |
| SOP availability and operator training | Compliance with quality system |
✅ 4. Performance Qualification (PQ)
| Parameter | Purpose |
|---|---|
| Equipment performance under actual load | Real batch or simulated process test |
| Consistency across 3 consecutive runs | Demonstrates reproducibility |
| Process parameters monitoring | E.g., temperature, pressure, speed, mixing time |
| Product quality testing | Finished product meets specification |
| Cleaning validation (if applicable) | No cross-contamination |
| Microbial/environmental monitoring (if sterile equipment) | Ensures cleanroom compatibility |
| User/operator feedback | Ensures usability and safety during real operation |
| Deviations or alarms during operation | Logged and investigated |
✅ Summary Table:
| Stage | Key Documents | Tests/Checks |
|---|---|---|
| DQ | URS, FDS, Risk Assessment | Design review, vendor compliance |
| IQ | Installation checklist, MOC, Calibration | Utility check, component verification |
| OQ | OQ protocol, test scripts | Functionality, alarms, calibration |
| PQ | PQ protocol, batch records | Real process, reproducibility, product testing |
📂 Documentation Must Include:
-
Protocols and reports for each stage (DQ/IQ/OQ/PQ)
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Raw data (printouts, logs)
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Calibration certificates
-
Deviations and corrective actions (if any)
-
Summary and final approval
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