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…

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. Source: Drug…

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…

In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Source: Drug GMP Report

Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues. Source: Drug GMP Report

The FDA has targeted several API manufacturers, finished drug manufacturers and supplement makers over GMP and other compliance issues. Source: Drug GMP Report

The FDA plans to lift an import alert against products from a Sun Pharma facility in Mohali, India. Source: Drug GMP Report

Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis. Source: Drug GMP…

The EMA is recommending that the European Commission suspend the sales of more than 300 generic drug formulations that were approved from flawed bioequivalence studies conducted at two of Micro…

India’s Ministry of Health is proposing that drug regulators and drugmakers implement several measures to improve the quality of drugs in the country’s supply chain, following a government estimate that…