QUALIFICATION OF IPQC INSTRUMENTS IN PHARMA

🧪 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.

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🎯 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.

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🛠️ 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.

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🔹 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.

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🧪 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.

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📘 Regulatory References

• EU GMP Annex 15 – Qualification and Validation
• WHO TRS 1019 Annex 3 – Equipment Qualification
• US FDA Guidance on Process Validation

1. URS of Analytical Balance
2. Installation Qualification of Analytical Balance
3. Operation Qualification of Analytical Balance
4. Performance Qualification of Analytical Balance
5. URS of DT Apparatus
6. Installation Qualification of DT Apparatus
7. Operation Qualification of DT Apparatus
8. Performance Qualification of DT Apparatus
9. URS of Friabilator
10. Installation Qualification of Friabilator
11. Operation Qualification of Friabilator
12. Performance Qualification of Friabilator
13. URS of Leak Test Apparatus
14. Installation Qualification of Leak Test Apparatus
15. Operation Qualification of Leak Test Apparatus
16. URS of Moisture Analyser
17. Installation Qualification of Moisture Analyser
18. Operation Qualification of Moisture Analyser
19. Performance Qualification of Moisture Analyser
20. URS of Sieve Shaker
21. Installation Qualification of Sieve Shaker
22. Operation Qualification of Sieve Shaker
23. Performance Qualification of Sieve Shaker
24. URS of Tablet Hardness Tester
25. Installation Qualification of Tablet Hardness Tester
26. Operation Qualification of Tablet Hardness Tester
27. Performance Qualification of Tablet Hardness Tester
28. Installation Qualification of Conductivity Meter
29. Operation Qualification of Conductivity Meter