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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. Read More
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. Read More
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 five years. Read More
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 key component of an effective audit. Read More
GMP woes for foreign and domestic facilities continued as the FDA issued three warning letters to Indian and Chinese factories as well as a U.S. facility over data integrity and quality control problems. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including ensuring GMP compliance and quality throughout supply chains. Read More
Sponsors should include clear assessments of necessary future quality improvement actions in their periodic safety update reports, not simply provide a list of adverse events or GMP problems, according to new guidance from the European Medicines Agency. Read More