We are excited to announce that our pharmaceutical facilities and analytical and stability testing facilities in Shanghai have successfully passed the European Medicines Agency (EMA) inspection for GMP compliance, with “no critical and no major findings.” This is the third consecutive time WuXi has passed the EMA inspection.
During the four-day 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 has consistently adhered to EMA’s GMP guidance.
EMA’s GMP certification is the prerequisite for implementing contract manufacturing for any product in the European Union, one of the world’s largest and major pharmaceutical markets. The certification is not only recognized and accepted among 30 EU member states, its inspection findings are also recognized by the United States, Canada, Australia, and Japan.