WuXi AppTech Passes EMA InspectionBy
WuXi AppTec, a contract R&D and manufacturing company, reports that its pharmaceutical facilities and analytical and stability testing facilities in Shanghai have passed the European Medicines Agency (EMA) inspection for good manufacturing practice (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 adhered to EMA's GMP guidance.
EMA's GMP certification is the prerequisite for implementing contract manufacturing for any product in the European Union.The certification is not only recognized and accepted among 30 European member states, its inspection findings are also recognized by the United States, Canada, Australia, and Japan, according to the company.