Analytical Quality Control News

Warning Letter caused by incomplete Impurity Profiles

In January 2025, the U.S. FDA issued a Warning Letter on its webpage due to the lack of evaluation of impurities - also during the stability studies.

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FDA Warning Letter for Chinese Contract Testing Laboratory

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.

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USP Announces Corrections to General Chapter <1132.1> on Residual Host Cell Protein Measurement

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.

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FDA Warning Letter: Focus on Quality Control of APIs and Excipients

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.

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US FDA: Carcinogenic Potency Categorization Approach for Nitrosamine Impurities

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".

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Revision of USP <1032> Design and Development of Biological Assays

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.

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FDA Warning Letter to Chinese Manufacturer of OTC Products

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.

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Warning Letter - No Testing for EC/DEG and other Deficiencies

In November, the FDA issued a warning letter to a manufacturer of topical products in France. In addition to inadequate testing of components used, e.g. for ethylene or diethylene glycol, the warning letter also includes a whole series of other deviations.

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English Translation of Supplement II to the Japanese Pharmacopoeia (JP18) Published

The official English translation of Supplement II to the Japanese Pharmacopoeia (JP) Eighteenth Edition is now available as a free download.

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PharmaLab 2024 Brief Summary - Save the Date for 2025!

The 12th PharmaLab Congress took place in November 2024 and the upcoming congress is already scheduled from 24-26 November 2025 in Düsseldorf/Neuss. Here, you will find a short overview along with some figures from last year’s congress.

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