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In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

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FDA sends warning letter to the manufacturer of a homeopathic honey product, among other things because of microbiological contamination with Bacillus spec. Due to the advertised use for children, there was a not insignificant risk..

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In May 2022, the US FDA inspected an Indian sterile manufacturer, revealing numerous deficiencies that have now led to a Warning Letter. Among other things, deficiencies in media fill, plant and cleanroom design, and environmental monitoring were cited.

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The U.S. Food and Drug Administration (FDA) has published two Warning Letters to manufactures of hand sanitizer drug products. In both cases, acetaldehyde and acetal impurities at unacceptable levels were found in several lots. The agency is concerned, because acetaldehyde is considered to be genotoxic, and potentially carcinogenic.

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Furthermore, the "Falsified Medicine Directive (2011/62/EU)" requires a "Written Confirmation" for the import of active pharmaceutical ingredients (APIs) from third countries. The APIs imported from countries on the so-called "White List" are an exception to this. In future, Canada will also be listed on this "White List".

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Swissmedic specifies its requirements for the validity of EU-GMP certificates in Switzerland.

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In the EudraGMDP database, results of European inspectors are published in so-called Non-Compliance Reports. In the period October-November 2022, there were two reports in the area of GMP, both of which were issued due to cross contamination.

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The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.

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The U.S. Food and Drug Administration (FDA) has published a so-called untitled letter to a US company. The FDA states that the firm violated the Drug Supply Chain Security Act (DSCSA). Specifically, the letter concerns a former subsidiary of the company that was a licensed pharmacy and wholesale drug distributor.

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The FDA has signed a Mutual Recognition Agreement on GMP inspections with Switzerland. It applies to both human and veterinary medicinal products.

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