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.

In Pharmeuropa, the “Comments concerning texts published in Issue 12.3” were published. These include explanations of the new, revised, and corrected texts adopted by the European Pharmacopoeia Commission, including Chapters 2.9.42 and 2.9.43 on dissolution testing.

The U.S. Food and Drug Administration has issued a Warning Letter to an API manufacturing site in India. Since 2023, approximately 1,500 laboratory incidents (including OOS results and major analytical events) have been recorded, and the authority identified systemic failures in the handling of Out-of-Specification (OOS) results, laboratory investigations, and the overall CAPA system.

PharmaLab 2025 took place from 24 to 26 November in Neuss, featuring nine parallel conferences and two pre-conference workshops with more than 100 presentations. This year, the ECA Analytical Quality Control Group (AQCG) organised a one-day conference track entitled “Analytical Quality and Lifecycle Concepts”. Moderated by Dr Christopher Burgess (AQCG Chairman), the track comprised a series of presentations and discussions.