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".
USP recently published a draft revision of Chapter <1032> Design and Development of Biological Assays, which will be available for comment until the end of January. This chapter is part of 5 USP chapters that deal with the topic of bioassasys.
A warning letter to a Chinese manufacturer of OTC drug products continues the series of FDA warning letters on the subject of inadequate testing of starting materials and components. In this case too, however, the warning letter goes beyond these deficiencies.
