Are You Calibrating Your Equipment According to GMP Standards?

When was the last time you checked your equipment calibration records?
In a GMP-compliant facility, proper calibration isn’t optional — it’s essential for ensuring product consistency, regulatory compliance, and audit success.

Failing to follow GMP calibration standards can result in product recalls, customer complaints, or even loss of certification.

🧭 What Does GMP Say About Equipment Calibration?

• GMP guidelines (including PIC/S, WHO, NPRA, and FDA) require:

  • Regular calibration of equipment that affects product quality or safety

  • Clear documentation and traceability of all calibration activities

  • Immediate action if equipment is found out of tolerance

⚠️ Risks of Poor Calibration Practices

• Incorrect measurements (weight, temperature, pH, etc.)

• Batch failures due to inconsistent process parameters

• Unreliable product testing results

• Cross-contamination from malfunctioning cleaning equipment

• Audit non-conformities due to missing or outdated calibration records

• Customer complaints due to product quality issues

✅ Key Equipment That Must Be Calibrated Under GMP

• Weighing scales and balances

• Thermometers and data loggers

• pH meters

• Pressure gauges

• Metal detectors

• Pasteurizers, autoclaves, ovens, and freezers

• Laboratory testing instruments

• Filling machines and checkweighers

🔍 What GMP Auditors Look for During Calibration Checks

📁 Calibration Records

• Calibration certificates with:

  • Date of calibration

  • Calibration results (pass/fail or tolerance)

  • Technician name and traceability

  • Next due date

📆 Calibration Schedule

• Evidence of planned and routine calibration

• Calendar system or logbook tracking due dates

🧪 Use of Calibrated Standards

• External calibration by ISO/IEC 17025-accredited labs

• In-house checks using traceable reference standards

⚠️ Handling of Out-of-Tolerance Equipment

• Immediate action taken (e.g., tag out, product hold, investigation)

• Evaluation of potentially affected batches

🏷 Equipment Labelling

• Calibration status labels showing:

  • Last calibration date

  • Due date

  • Equipment ID or serial number

🛠️ Best Practices for GMP-Compliant Calibration

1. Establish a Calibration Program

• Maintain an equipment master list

• Define frequency based on:

  • Manufacturer recommendation

  • Process risk

  • Regulatory guidelines

2. Use Accredited Calibration Services

• Work with ISO 17025 certified labs for critical equipment

• Ensure certificate traceability to national/international standards

3. Train Staff on Equipment Use and Calibration Awareness

• Teach operators to recognize:

  • Equipment drift

  • Damage or malfunction

  • Labeling and documentation importance

4. Control Non-Calibrated Tools

• Clearly label or segregate “For Reference Only” equipment

• Prevent use in critical manufacturing steps

5. Audit Your Calibration System Regularly

• Review records and calibration effectiveness during internal audits

• Use non-conformances as learning and improvement points

🧠 Pro Tip: Calibration Is Not Just a QA Responsibility

• In GMP, everyone is responsible for ensuring equipment is in good condition

• From production to maintenance — teamwork ensures compliance and safety

📌 Final Thoughts

Calibration is one of the simplest ways to protect your product integrity, but also one of the most overlooked.

Ask yourself:
✅ Are your records up to date?
✅ Are you using traceable standards?
✅ Are your operators aware of calibration labels and statuses?

If not — it’s time to act before an auditor does.

💼 Need help building or reviewing your GMP calibration program?
At CAYS Scientific, we assist Malaysian manufacturers with:
✔️ Equipment listing and criticality assessment
✔️ Calibration SOPs
✔️ Recordkeeping systems
✔️ Internal GMP audit support

📞 Contact us to ensure your calibration practices are truly GMP compliant.