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Manufacturing Compliance Updates In Brief From US FDA And The EU

Executive Summary

FDA issues five more drug GMP warning letters to drug manufacturers and active ingredient manufacturers at sites in India, China, and the US exhorting them to do a better job of testing ingredients and final products and to manage cross-contamination risks better. UK MHRA withdraws the GMP certificate for one Taiwanese API maker for its lack of knowledge of sterile processing. Meanwhile, FDA adds an Indian facility to its drug GMP import alert.

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FDA Expects Drug GMP Warning Letter Tally To Reach 90 This Year

FDA official says OTC firms that have not been inspected before and have limited to no knowledge of US GMP requirements appear to be driving the upward surge in drug GMP warning letters issued by the agency since January. One especially “scary” warning letter trend is manufacturers not testing incoming ingredient for diethylene glycol (DEG) or ethylene glycol (EG). Over the years, DEG contamination in pharmaceuticals has resulted in lethal poisoning incidents around the world.

Manufacturing Compliance Updates In Brief From US FDA And EU

Data integrity problems reemerged as a theme in seven recent drug GMP warning letters the US FDA sent to drug and active ingredient manufacturers at sites in South Korea, Australia, Taiwan, China, Ireland and France. Investigators also are seeing problems with inadequate testing of components and inattention to investigating batch failure. FDA issued a Form 483 report to Glenmark in India for inadequate cross-contamination controls, in the EU, the Spanish Agency of Medicines and Medical Devices withdrew one Spanish drug maker’s GMP certificate for multiple GMP violations.

US FDA Crossing Off More Foreign OTC Firms On Globalization Checklist

FDA issued 39 warning letters to OTC drug facilities, most of them outside the US, in 2017, a number significantly boosted by an initiative to inspect a total of 1,000 foreign drug manufacturers from January 2017 through September 2019 , says CDER compliance director Donald Ashley. Many GMP violations behind FDA's warning letters concerned “rudimentary" requirements.

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