From routine sample prep to analytical testing, lab balances are foundational to generating quality data. Yet in clinical and pharmaceutical settings, where even minor discrepancies can compromise compliance and threaten patient outcomes, relying on “good enough” weighing practices is not an option.
Industry guidelines such as USP Chapter <41> and <1251>, and Ph. Eur. Chapter 2.1.7 provide detailed frameworks for minimum sample weights, performance testing and qualification, calibration, and repeatability testing. Labs must also meet requirements for data integrity as defined under 21 CFR Part 11 and GAMP, ensuring traceability, security, and reliability of electronic weighing data.
This resource collection offers insights into analytical balance best practices, calibration, and regulations. With guidance on implementing and maintaining these standards, clinical labs can improve weighing accuracy, strengthen compliance and data integrity, and support audit readiness.
Download this resource compendium to explore:
- Testing requirements for lab balances from USP Chapters <41> and <1251>, and Ph. Eur. Chapter 2.1.7
- Key elements of data integrity and compliance with GAMP and 21 CFR Part 11
- How to uphold quality using analytical balances in pharmaceutical analysis, including HPLC, mass spectrometry, microbiological tests, and gravimetric methods
