Analytical Quality Control News

In the Pharmacopeial Forum, PF 51(2), a new version of USP General Chapter <621> Chromatography has been published. The System Sensitivity and Peak Symmetry subsections were further modified to clarify the applications of these new requirements. Comments can be submitted until 31 May 2025.

In the Pharmacopeial Forum, PF 51(2), a proposed revision of USP Chapter <1058> Analytical Instrument Qualification has been published for comments. The chapter provides general guidance in a scientific, risk-based approach for carrying out an analytical instrument and system qualification (AISQ). Comments can be submitted until 31 May 2025.

Eurachem has recently published a leaflet titled “Fitness for the intended use of analytical equipment and systems”. The document outlines the role and handling of analytical equipment and systems in the process of a laboratory dealing with the analysis of chemical elements and molecules. It was prepared by the Eurachem Analytical Equipment and Systems Qualification Working Group, which is chaired by Dr. Ernst P. Halder.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American contract testing laboratory, emphasizing that it considers contractors as extensions of the manufacturer’s own facility. The authority identified critical deficiencies, including the failure to validate microbiological testing methods in accordance with USP standards and inadequate investigation of temperature and humidity deviations in laboratory equipment.