🧪 Qualification of IPQC Instruments in Pharma
✅ What are IPQC Instruments?
IPQC (In-Process Quality Control) instruments are devices used during manufacturing to monitor and control product quality in real time.
Examples:
- Tablet hardness tester
- Friability tester
- Moisture analyzer
- Weight checker
- pH meter
Because they directly impact product quality decisions, their qualification is mandatory under GMP.
🎯 Objective of Qualification
To provide documented evidence that each instrument:
- Is suitably installed (per manufacturer specs).
- Performs consistently within defined limits.
- Meets all GMP and regulatory requirements.
- Is fit for its intended use.
🛠️ Qualification Lifecycle
The process follows four main stages (per GAMP 5 and WHO guidelines):
1️⃣ Design Qualification (DQ)
- Confirm the selected model/specifications meet intended purpose.
- E.g., range, accuracy, GMP compliance.
2️⃣ Installation Qualification (IQ)
- Verify the instrument is installed correctly:
- Utilities (power, compressed air)
- Environment (temperature, vibration)
- Calibration certificates
- Document serial numbers, configuration, accessories.
3️⃣ Operational Qualification (OQ)
- Test functional parameters against pre-approved acceptance criteria:
- E.g., hardness tester—force range, reproducibility.
- Check alarms and interfaces.
4️⃣ Performance Qualification (PQ)
- Confirm instrument performs reliably under actual operating conditions with real samples.
- Simulate routine use and variability.
🔹 Supporting Requirements
- Calibration: Initial and periodic traceable calibration.
- SOPs: Operation, cleaning, calibration, maintenance.
- User Training: Qualified personnel documentation.
- Change Control: For any modifications.
- Maintenance Plan: Schedule preventive maintenance.
🧪 Example: Qualification Steps for a Tablet Hardness Tester
| Step | Activity |
|---|---|
| DQ | Confirm measurement range, resolution, compliance. |
| IQ | Install per manual, verify connections, record details. |
| OQ | Test calibration weights, check repeatability. |
| PQ | Measure actual production tablets and compare results. |
📘 Regulatory References
- EU GMP Annex 15 – Qualification and Validation
- WHO TRS 1019 Annex 3 – Equipment Qualification
- US FDA Guidance on Process Validation
- URS of Analytical Balance
- Installation Qualification of Analytical Balance
- Operation Qualification of Analytical Balance
- Performance Qualification of Analytical Balance
- URS of DT Apparatus
- Installation Qualification of DT Apparatus
- Operation Qualification of DT Apparatus
- Performance Qualification of DT Apparatus
- URS of Friabilator
- Installation Qualification of Friabilator
- Operation Qualification of Friabilator
- Performance Qualification of Friabilator
- URS of Leak Test Apparatus
- Installation Qualification of Leak Test Apparatus
- Operation Qualification of Leak Test Apparatus
- URS of Moisture Analyser
- Installation Qualification of Moisture Analyser
- Operation Qualification of Moisture Analyser
- Performance Qualification of Moisture Analyser
- URS of Sieve Shaker
- Installation Qualification of Sieve Shaker
- Operation Qualification of Sieve Shaker
- Performance Qualification of Sieve Shaker
- URS of Tablet Hardness Tester
- Installation Qualification of Tablet Hardness Tester
- Operation Qualification of Tablet Hardness Tester
- Performance Qualification of Tablet Hardness Tester
- Installation Qualification of Conductivity Meter
- Operation Qualification of Conductivity Meter