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Contamination control measures also play an important role in the case of non-sterile medicines. A new Q&A from the EMA answers questions on this topic.

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The European QP Association (EQPA) is committed to providing practical tools for Qualified Persons (QPs) to support them in their day-to-day responsibilities. One such tool is QPSHARE, which all members can access free of charge to foster audit collaboration.

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The FDA inspected the site of a Japanese pharmaceutical manufacturer in Tokyo in November 2025 and found, amongst other things, fundamental deficiencies in the aseptic manufacturing processes. Due to the severity of the violations, a Warning Letter has now been issued.

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Almost every week, the US FDA publishes Warning Letters in which it criticises companies for inadequate CAPA measures and insufficient Quality Oversight. Now two sites in the EU have been affected

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Amazon.com, Inc. following an FDA review of labeling and marketing claims for drug products purchased via the website and distributed to U.S. consumers through the “Fulfillment by Amazon” service.

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In a recent blog post, the U.K. MHRA has outlined examples of responses to inspection reports that were generated by artificial intelligence (AI), which, in some cases, contain alarming errors.

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For manufacturers of active substances, compliance with GMP rules according to ICH Q7 is the key benchmark for the appropriate manufacture of active pharmaceutical ingredients. The requirements are aimed at ensuring that the active substance is manufactured, tested, stored and supplied in the required quality and purity.

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The EMA has published the revised Q&A document 'Questions and answers on the impact of the Mutual Recognition Agreement (MRA) between the European Union and the United States as of 9th June 2026'. This revision reflects the latest developments in the implementation of the EU-US MRA, particularly with regard to veterinary medicinal products.

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The Australian TGA is planning to publish GMP certificates on its website and is looking for feedback on this idea in a Consultation Paper and survey.

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A recent FDA Warning Letter exposes gaps in equipment suitability, facility upkeep, and quality oversight and shows how an empowered QU can prevent these failures before they reach the inspection room.

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