WuXi AppTec’s pharmaceutical facilities and analytical and stability testing facilities in Shanghai have passed the European Medicines Agency (EMA) inspection for GMP compliance, with “no critical and no major findings.” This is the third successful EMA inspection.
 
Inspectors from Sweden Medical Product Agency evaluated WuXi’s quality system, covering GMP small molecule drug product manufacturing, packaging and labeling, as well as GMP analytical and stability testing. The inspection outcome confirms that WuXi’s quality system adheres to EMA’s GMP guidance.
 
EMA’s GMP certification is the prerequisite for implementing contract manufacturing for any product in the EU and is recognized and accepted among 30 EU member states, as well as the U.S., Canada, Australia, and Japan.
 
“We are excited to have once again successfully passed EMA’s GMP inspection, which showcases WuXi’s commitment to world-class quality standards,” said Dr. Ge Li, chairman and chief executive officer of WuXi AppTec, “We will continue to improve our quality management system and keep providing the highest-quality products and services for our global customers.”