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Drugmakers in the EU have less than seven months to conduct risk assessments of all the excipients they use under good manufacturing practices guidelines imposed by the European Commission. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
Contract manufacturer Pernix Manufacturing received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
Pfizer’s Dalian, Liaoning, China, facility received a six-observation Form 483 for retesting failed samples, poor record controls and using an open pit for a urinal. Read More
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made. Read More
The FDA cited Novartis’ Vaccines and Diagnostics facility located in Liverpool, UK, for numerous lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11. Read More
The FDA has cited data integrity as one of the most important GMP issues because it lies at the crux of all GMP systems. John Avellanet, managing director and principal at Cerulean Associates, sat down with FDAnews to talk about how companies should be handling their data.Read More
IPEC-Americas is urging excipient makers to follow its voluntary guideline on stability testing in the wake of recent requests by foreign regulators for stability data. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance. Read More
The FDA issued final guidance clarifying when large drug compounding facilities must register with the agency, making only a few changes to a draft version released in February. Read More