The recording of the session, a Q&A paper, and the guidance document are available in the members’ area. If you are not yet a member, you can register here for free.
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 EMA has recently published an update to its question and answer catalog for biological medicinal products. Among other things, it also addresses the question of when endotoxin masking effects must be taken into account for biological products.
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.
The International Organization for Standardization (ISO) has published ISO/TR 33402:2025 "Good practice in reference material preparation". This new technical report replaces ISO Guide 80:2014 and expands its scope to cover all types of matrix reference materials, not just those used for statistical quality control.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter highlighting significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). A facility in China was found to have multiple compliance deficiencies based on a review of records submitted in response to an FDA request.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter following an inspection conducted in September 2025. The contract testing laboratory in question analyzed active pharmaceutical ingredients (APIs) and intermediates for compliance with regulatory standards for the U.S. market.
The United States Pharmacopeia (USP) has identified necessary minor corrections to General Chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry. All changes will become effective on 01 May 2025.
At the end of January, the U.S. Food and Drug Administration (FDA) published a new Warning Letter. The document, addressed to a Turkish OTC manufacturer, specifically criticizes the testing of incoming components and release testing.
In January 2025, the U.S. FDA has published in its newsroom on the CDER website the article called "Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach".
