Metrology of weighing in the pharmaceutical industry

Abstract

Accurate weighing results are key for quality control and production processes within the pharmaceutical industry. In the past, the industry has sometimes lacked a sound metrological understanding of weighing, specifically concerning the performance verification of weighing instruments that includes calibration and routine testing activities. New pharmaceutical regulations in conjunction with established weighing standards help closing this gap. Their application should steer the pharmaceutical industry towards building a risk-based quality management system for weighing applications, built on proven metrological concepts. As one consequence, outdated strategies of controlling the quality of weighing results can be more easily removed and substituted by state-of-the-art weighing practices. Infamous examples of outdated practices are the perception of calibration being a process of just putting one test load on the balance, or the daily balance check that lacks a sound metrological foundation. A new General Chapter within the European Pharmacopoeia applicable for balances used for analytical purposes provides a good opportunity for reviewing and updating existing metrological concepts and quality management systems for weighing in the pharmaceutical industry.

Keywords

• Weighing
• Calibration
• Performance verification
• Pharmaceutical industry
• Quality management system
• Risk-based approach