WuXi Biologics, a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP inspection by Health Canada for its drug substance facility (MFG2) in Wuxi city. There were no observations during the inspection, demonstrating that the company’s premier quality system is in full compliance with global regulatory requirements.
The comprehensive inspection was conducted by three inspectors and covered the facility’s quality processes and entire production system. So far, WuXi Biologics has successfully completed nearly 20 regulatory inspections conducted by eight different agencies including the U.S. FDA, EMA and NMPA, 13 of which were conducted this year.
“We are very proud of successfully completing another regulatory inspection,” said Dr. Chris Chen, CEO of WuXi Biologics. “Our world-class quality system being certified by various regulatory agencies in the U.S., EU, China, Japan, Brazil, and Singapore is a strong testament to our commitment to maintaining the highest global quality standards. With those standards as our cornerstone, WuXi Biologics will continue to enable our global partners to provide life-saving treatments quickly and effectively to benefit patients worldwide.”