The Ph. Eur. Chapter 2.1.7 applies to pharmaceutical quality control laboratories and importers in countries where this regulation is enacted. It defines requirements for calibration, performance testing and documented evidence to support compliance.

Please note: It does do not apply to pharmaceutical manufacturing operations.

Pharmacopoeias such as USP, Ph. Eur., JP, ChP, and IPC require documented evidence that a balance is suitable for its intended use. This includes calibration with measurement uncertainty and periodic performance verification. Some pharmacopoeias also recommend applying a safety factor or safety margin to further increase confidence in weighing results. A combination of the Calibration Certificate and Pharmacopoeia Certificate provides comprehensive documentation of these requirements, supporting compliance and audit readiness.

A combination of the Calibration Certificate and Pharmacopoeia Certificate provides comprehensive, audit-ready documentation. The Calibration Certificate records calibration data and measurement uncertainty, while the Pharmacopoeia Certificate documents compliance with applicable pharmacopoeia requirements, simplifying audit preparation and compliance verification.

No. In addition to calibration, pharmacopoeias require ongoing verification of balance performance through repeatability and accuracy testing. Both calibration and performance assessments are necessary to support compliance.

The ACC documents calibration results, including measurement uncertainty. The Pharmacopoeia Certificate documents repeatability and accuracy assessments and provides a compliance statement against the applicable pharmacopoeia acceptance criteria. Together, they provide comprehensive compliance documentation.

Compliance is maintained through risk-based routine performance testing. GWP Verification helps establish appropriate testing frequencies, methods, test weights and test tolerances, helping ensure ongoing compliance and audit readiness throughout the balance lifecycle.