Analytical Quality Control News

Eurachem has published a new Guide titled The Fitness for Intended Use of Analytical Equipment and Systems – A Laboratory Guide to the Life Cycle of Analytical Equipment and Systems, their Qualification and Related Topics. The document addresses the entire life cycle and qualification of analytical equipment and systems used in laboratories, ranging from simple apparatus to complex computer-based systems, and promotes an integrated, risk-based approach to ensure fitness for intended use.

How does your organization handle Out-of-Specification (OOS) results in practice? The ECA Analytical Quality Control Group (AQCG) invites you to share your experience and contribute to the ongoing update of AQCG OOS guidance. We would be pleased if you would participate in a short survey, which takes only a few minutes to complete.

In December 2025, Revision 3 of the 'Guideline on stability testing for applications for variations to a marketing authorization' was published on the EMA website. It entered into force on 15 January 2026.

Phase 3 (ongoing/continued process verification) is the longest phase in the validation life cycle. Many companies use statistical process control (SPC) for this purpose. Concept Heidelberg conducted a survey for the ECA specifically on this topic. Among other things, the ECA wanted to know whether SPC is also used in other areas, which control charts are used, etc. Read the results of the survey in Part I.