The FDA expects drugmakers to have quality agreements with their suppliers, but how those agreements are crafted says a lot about a company’s internal auditing program. Source: Drug GMP Report

The European Medicines Agency and the European Commission today published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Source: Drug GMP Report

The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Source: Drug GMP Report