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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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Version 4.0 of the technical interpretation on legal requirements for foreign trade and supply chain traceability defines concrete and enforceable obligations.

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During an inspection of a US OTC manufacturer in June 2026, the US FDA identified a significant risk of cross-contamination between pharmaceutical and non-pharmaceutical production and issued a Warning Letter.

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