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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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The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturing facility in Illinois. The agency highlights three interlinked failures: insufficient incoming-material testing, lack of stability data to justify expiry, and data integrity / quality unit oversight weaknesses.

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In the pharmaceutical industry, the management of impurities - in particular, control via suitable analytical methods and reporting requirements - is clearly regulated. The main requirements are set out in the ICH Q3B(R2) guideline. What are the requirements for testing for impurities in the pharmaceutical industry?

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Find out what the GMP Auditor Association was working on and accomplished in the first four months of 2026 - in the latest report.

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The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturing facility in South Korea, illustrating how missing method validation can rapidly escalate from a QC topic to a broader compliance, supply, and market-access issue.

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