The European Medicines Agency answered the most pressing questions related to the United Kingdom’s exit from the European Union, making it clear UK-made products would be subject to import quality…

Significant GMP violations and repeating problems at U.S. companies across the drug supply chain lead the FDA to issue warning letters, including a lack of product testing at an Oklahoma…

What’s the best way to get ready for an FDA GMP inspection? Practice, says international quality expert Thomas Peither. Self-inspection or a fresh set of eyes in the form of…

FDA Commissioner Scott Gottlieb spent the early weeks of his tenure in the agency’s top job laying out his priorities before senior FDA staff and members of Congress and announcing…

President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety and quality of drugs, which would cut federal spending…

FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure in mid-May, aligning inspection staff into seven product categories — more closely mirroring the organization of the…

The FDA issued a flurry of Form 483s to drugmakers in the United States, Japan and India for issues ranging from inadequate record-keeping to cleanliness issues. Source: Drug GMP Report

Manufacturers and industry groups urged the FDA to develop guidance on its processes for assigning a lead center for the quality review of a combination product. Source: Drug GMP Report

Australia’s drug regulatory agency is urging drugmakers to reassess their quality control and data management systems after agency officials found frequent data integrity violations during GMP inspections over the past…

Responses to internal audit reports are critical for GMP compliance because they fall under CAPA — so how a company responds to the findings of an internal audit is a…