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At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared GDP relevant document. The German-language resource entitled "Inspektion der Eignung von Transportprozessen" focuses on transport verification and its inspections by the competent authorities.

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The FDA uncovered serious deficiencies in the aseptic area during an inspection of a US manufacturer. Deficiencies in smoke studies, media fills, pressure monitoring and cleaning validation are listed.

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In August 2023, the U.S. FDA issued a Warning Letter to the US American company "Cosmobeauti Laboratories & Manufacturing Inc." after having inspected its site in March 2023. The significant violations of cGMP regulations for drug products, which are mentioned in the Warning Letter, can be checked here.

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PIC/S is a collaboration of regulatory agencies in the field of GMP for human and veterinary medicines. The goal of PIC/S is to provide harmonized standards and training to ensure that one inspection per site will also be recognized by every other authority. The 2022 report provides an overview of PIC/S activities for that year. What does it include?

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Just recently, we reported on a Warning Letter regarding a manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. The FDA has now published a whole series of Warning Letters that revolve around the same topic.

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When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for road transport operations.

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The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. During an inspection at an Indian company, the FDA investigators observed several GMP violations concerning inadequate investigation of humidity excursions, data integrity deficiencies, and inadequate testing of component lots used to manufacture the OTC drug products.

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At the beginning of August, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. As in several cases in recent months, it is again about a US manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. In addition, a number of other CGMP violations are documented.

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The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of GMP for medicinal products has entered into force. It applies to both human and veterinary medicinal products.

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Republican Congress members are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA regulations and express this in a letter to the FDA Commissioner.

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