WuXi AppTec’s Pharmaceutical Development Service and Analytical Service Passes EMA Inspection
May 12, 2016
Shanghai, May 11– WuXi AppTec (WuXi), a leading open-access R&D capability and technology platform company serving the global pharmaceutical, biotechnology and medical device industries, today announced that its pharmaceutical facilities and analytical and stability testing facilities in Shanghai 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.
"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 CEO 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."
About WuXi AppTec
WuXi AppTec is a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries. As a research-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services throughout the drug and medical device R&D process. WuXi AppTec is also building a platform to provide clinical diagnostic services directly to physicians and their patients globally. WuXi AppTec's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. For more information, please visit: http://www.wuxiapptec.com.
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