Eurachem publishes Leaflet on Analytical Equipment and Systems

As part of the Analytical Instrument Qualification and System Validation track during PharmaLab 2024, Dr. Ernst P. Halder presented an overview of the content and the current status of the Eurachem Guide for "The Fitness for Purpose of Analytical Equipment", which is currently under development. 

In this context, on 27 January 2025, Eurachem published a new leaflet titled "Fitness for the intended use of analytical equipment and systems." The two-page document was developed by the Eurachem Analytical Equipment and Systems Qualification Working Group, which is chaired by Dr. Halder.

The new document provides an introduction to the fitness for intended use of analytical equipment and systems. It highlights the role of such equipment in laboratory settings, focusing on the analysis of chemical elements and molecules. It discusses the importance of validation and qualification to ensure the equipment and methods meet quality standards and produce reliable results.

Key points include:

• Analytical Method and Equipment: The analytical process relies on validated methods and equipment that are fit for their intended purpose. Performance stability and long-term reliability are emphasized, especially when transferring methods between equipment.
• Pyramid of Quality: To ensure reliable results, the foundation (equipment and methods) must be under control and validated, supported by quality assurance measures at various levels.
• Calibration and Robustness: Calibration alone is insufficient for proving fitness for use. Robustness tests during development and validation help evaluate the impact of environmental and operational variables.
• Equipment Lifecycle: The lifecycle begins with defining user requirements, covering operational ranges, compatibility, and data integrity (e.g., ALCOA+ principles). Sustainability and long-term accessibility of data are also critical.
• Standards and Guidance: ISO standards like ISO/IEC 17025 and industry-specific guidelines (e.g., Eurachem) provide frameworks for ensuring compliance and effective use of analytical equipment and systems.

The leaflet (first English edition, December 2024) is available for download on the Eurachem website.