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Although the document "The worksharing procedure for the assessment of Active Substance Master File (ASMF)" by the two coordination groups CMDh and CMDv had only just been updated in May 2024, another amendment was made at the end of 2025. The current revision 5 now complies with the requirements of the new "Variations Regulation" and can be viewed on the CMDh's website.

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In July 2025, the FDA inspected a US contract manufacturer of OTC drugs. The Warning Letter describes in particular the lack of physical separation, inadequate cleaning of shared equipment, and deficiencies in the quality system. To make matters worse, the FDA had already pointed out similar deficiencies in 2018.

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Back in August 2025, the US FDA inspected an Indian manufacturer of solid dosage forms and identified serious GMP deficiencies. The complaints relate in particular to inadequate investigations of quality defects in tablets, deficiencies in the cleaning of non-dedicated equipment and deficiencies in the cleaning validation programme.

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When it comes to supplier qualification, it is unfortunately still often forgotten that audits or audit reports are only one component of supplier qualification, albeit an important one. Read on to find out what else is involved.

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Annex 15 is about to become far more relevant for API manufacturers. Stronger requirements for deviation investigations and process understanding will raise the bar for quality oversight across the supply chain.

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The 'Reflection paper on the qualification of non-mutagenic impurities' was published on the EMA website at the beginning of February 2026. It is intended to supplement the existing guidelines for non-mutagenic impurities (NMI) with regard to qualification and safety assessments.

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In December 2025, updated documents on the topic "Variations" were published on the HMA/CMDh website. These include, for example, Chapter 7 "CMDh BPG on Variation Worksharing" of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" and the "EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only."

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In March 2025, the FDA identified serious GMP deficiencies during an inspection of a US manufacturer of sterile OTC products and contract testing laboratories. After the manufacturer's response to the Form 483 report was deemed insufficient, a Warning Letter was issued.

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In January 2026, the Q&A document 'Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)' was finally published on the EMA website.

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In December 2025, the "Questions & Answers (Q&A)" document relating to centralized authorization procedures was updated again and published on the website of the European Medicines Agency (EMA). The updates and changes mainly relate to chapters 2 and 5 of the list of questions "European Medicines Agency pre-authorization procedural advice for users of the centralized procedure."

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