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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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In January 2025, the Task Force "Data Integrity" of the Quality Group of APIC, a sector group of the European Chemical Industry Council (CEFIC), published version 2 of the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. Updated and new questions and answers can be found in the "Password management" and "Access management" sections.

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The new version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in February 2025 and is available on its website in Portuguese and in English language.

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After inadequate root cause analyses were repeatedly the subject of FDA Warning Letters, another one was published on this topic. This time for a global company with a site in the USA.

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The US Food and Drug Administration (FDA) has identified serious violations of Current Good Manufacturing Practice (CGMP) regulations during a review of documents submitted by Akron Formulations India Private Limited, a manufacturer of OTC products.

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The Supplement 11.8 to the European Pharmacopoeia (Ph.Eur.) is now available. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia - holder) are required to adapt their specifications and thus the respective CEPs to comply with the new monographs by July 01, 2025.

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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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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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At the beginning of December, it was announced in the EDQM website newsroom that the Brazilian health authority ANVISA has started to recognise evaluation reports and documents from other authorities as part of its assessments.

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Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for fiscal year 2024 (October 2023 – September 2024). As in previous years, we have conducted an evaluation regarding deficiencies in the stability program.

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