GMP News

FDA Warning Letters of the Fiscal Year 2022: the "Top Ten" GMP Deficiencies

The analysis of the Warning Letters sent out in fiscal year 2022 offers a revealing overview of what FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" GMP violations.

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FDA Warning Letter again Highlights the Importance of Analytical Testing for Hand Sanitizers Manufacturers

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. Therein, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, a manufacturer of OTC drug products had been found to have significant deficiencies in these areas.

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APIC: New Update of the ICH Q7 "How to do" Document

The latest version (version 16) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients was finalised in July 2022 and published on the new APIC (Active Pharmaceutical Ingredients Committee) website at the end of October. The document further on aims to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

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FDA criticises Root Cause Analysis and CAPA in a Warning Letter

In a Warning Letter to a US manufacturer, the FDA criticises investigations after deviations in the media fill. Also, derived CAPA measures did not go far enough for the FDA.

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FDA sends Warning Letters to Amazon and Walmart

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

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