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During an inspection of a US manufacturer of OTC products in March 2025, the FDA identified serious violations of GMP requirements for finished medicinal products. Among other issues, the manufacturer had purchased the water for its production from a grocery store. This resulted in a warning letter from the FDA. Continue reading.

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Since 07 July 2025, three new draft guidance documents have been available on the EMA website, which can be commented on until 07 October 2025. These include Chapter 4, Annex 11 and Annex 22.

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In April 2025, the WHO published the new guideline ‘TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products’ on its website, which must be taken into account by manufacturers and packagers of excipients, active ingredients, processing aids and finished medicinal products. It should be noted that WHO Annex 2 is to be regarded as a supplement to the existing GMP guidelines and their requirements with regard to nitrosamines, as set out, for example, in ICH M7 (R2).

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In July, the U.S. FDA (U.S. Food and Drug Administration) published an announcement on its website regarding the publication of a large number of so-called "Complete Response Letters (CRLs)". It is already mentioned that further CRLs are to follow in the future.

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The FDA inspection at an Indian manufacturer revealed serious violations of GMP requirements, in particular unsustainable hygienic conditions in the production and storage areas.

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An FDA inspection revealed serious CGMP violations related to sampling, testing, and quality oversight at a U.S.-based drug manufacturer, underscoring the critical importance of scientifically sound sampling strategies.

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The FDA published the final Guidance for Industry Conducting Remote Regulatory Assessments - Questions and Answers. The final guidance describes how FDA will use Remote Regulatory Assessments (RRAs) for FDA-regulated products.

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A recent FDA Warning Letter highlights GMP violations at a U.S. manufacturer of over-the-counter (OTC) drug products, including missing microbiological testing, lack of stability data, and inadequate raw material controls.

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The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2024 Data", containing some interesting results that not everyone may have expected.

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Malta's Medicines Authority recently issued two GMP non-compliance statements: One to a manufacturer of cannabis-based medicinal products and another to a Quality Control testing laboratory for the analytical testing of non-sterile dosage forms (specifically for medical Cannabis products).

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