Calibrate Laboratory Balances Regularly Using Certified Weights

Always Calibrate Laboratory Balances with Certified Weights

Remember: All lab balances must be calibrated using certified weights to ensure measurement accuracy and GMP compliance.

Why This Matters in GMP

Balances are among the most critical instruments in a pharmaceutical laboratory. They are used for weighing reference standards, samples, and reagents. Even minor inaccuracies can cascade into major deviations in test results, batch failures, or incorrect formulation. Regular calibration using traceable, certified weights guarantees that the balance performs within defined tolerance limits. Using uncertified weights or skipping calibration increases the risk of undetected errors. Calibration also supports audit readiness and strengthens trust in analytical results. It ensures that data used in release decisions and regulatory submissions is both accurate and verifiable.

Also Read: How NMPA GMP Affects the Cost and Efficiency of Pharmaceutical Manufacturing

Regulatory and Compliance Implications

FDA 21 CFR Part 211.68 and 211.160 require calibration and validation of laboratory equipment. EU GMP and WHO GMP mandate the use of certified standards and documented calibration intervals. Schedule M outlines requirements for accuracy checks, traceability, and recalibration. Regulatory bodies check calibration certificates, balance logs, and standard weight traceability. Missed calibration schedules or use of uncertified weights can lead to serious observations, including invalidation of testing data. Calibration practices must be documented, reviewed, and aligned with risk-based equipment qualification programs.

Implementation Best Practices

Use certified, traceable weights verified by national metrology institutes (e.g., NIST, NABL).
Establish daily, weekly, and periodic calibration schedules with record formats.
Document calibration readings, deviations, and corrective actions clearly in equipment logs.
Train analysts on proper weight handling and balance leveling techniques.
Label balances with next due calibration date and prevent use if overdue.

Also Read: Never Use Trial Batches for Commercial Release Under GMP

Regulatory References

FDA 21 CFR Part 211.68 – Automatic, Mechanical, and Electronic Equipment
FDA 21 CFR Part 211.160 – Laboratory Controls
EU GMP Chapter 3 – Equipment
WHO GMP – Instrument Calibration Guidelines
Schedule M – Laboratory Equipment Calibration