Equipment Qualification and Calibration—A Critical Part of Good Laboratory Practices (GLP)

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📌 Equipment Qualification and Calibration: 

🔍 Introduction

In regulated industries like pharmaceuticals, biotechnology, and analytical labs, precision and compliance are non-negotiable. One cornerstone of achieving these goals is equipment qualification and calibration—a critical part of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO standards.

⚙What Is Equipment Qualification?

Equipment Qualification (EQ) is a documented process that ensures equipment is designed, installed, operated, and performs according to its intended purpose.

📋 Stages of Equipment Qualification:

Stage

Description

DQ – Design Qualification

Verifies that equipment specifications meet intended purpose.

IQ – Installation Qualification

Confirms equipment is received and installed correctly.

OQ – Operational Qualification

Validates that the equipment functions as expected under defined conditions.

PQ – Performance Qualification

Demonstrates consistent performance in the actual working environment.

What Is Calibration?

Calibration is the process of configuring an instrument to provide a result for a sample within an acceptable range. It ensures measurement accuracy by comparing with a known standard.

📐 Why Calibration Matters:

  • Ensures traceability to national/international standards
  • Prevents data integrity issues
  • Supports regulatory compliance (FDA, MHRA, NABL)

🔁 Difference Between Qualification and Calibration

Aspect

Qualification

Calibration

Purpose

Ensure suitability for intended use

Ensure measurement accuracy

Frequency

Once during lifecycle or after major changes

Periodically (monthly, quarterly, annually)

Outcome

Validated performance

Verified accuracy

Regulatory Role

Part of validation lifecycle

Part of routine maintenance

✅ Best Practices for Qualification and Calibration

  • Maintain a Master Validation Plan (MVP) and Calibration Schedule
  • Use calibrated and traceable reference standards
  • Keep detailed records with version control and audit trails
  • Conduct risk-based assessments for requalification
  • Implement training for technical personnel

📎 Regulatory References

  • ICH Q8/Q9/Q10
  • WHO TRS 937 Annex 4 (for equipment in pharmaceutical manufacturing)
  • 21 CFR Part 211 (GMP for finished pharmaceuticals)
  • OECD GLP Principles

✍Conclusion

Both equipment qualification and calibration are foundational pillars of quality assurance. They not only ensure that laboratory and production results are reliable but also protect organizations from compliance risks. Building a robust qualification and calibration program is a step toward operational excellence.


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