Manufacturing Compliance Updates In Brief From US FDA And EU

FDA recently issued seven drug GMP warning letters to drug manufacturers and active pharmaceutical ingredient manufacturers in South Korea, Australia, Taiwan, China, Ireland and France for data integrity problems, not adequately testing components in drug products and for lacking validation plans to ensure manufacturing processes are in a state of control. FDA also posted a Form 483 report it had issued to Glenmark in India. In the EU, the Spanish Agency of Medicines and Medical Devices withdraws an EU GMP certificate for one Spanish drug maker for multiple GMP violations.