SHANGHAI, March 31 /PRNewswire-Asia/ -- WuXi AppTec announced today that its Bioanalytical Services (BAS) unit had been inspected by the U.S. Food and Drug Administration (FDA) without the issuance of a Form 483, which is used to report any non compliance issues after a site inspection.
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WuXi’s Bioanalytical Services (BAS) was established in 2005. BAS provides Good Laboratory Practice (GLP)-compliant services to analyze small-molecule drugs using liquid chromatography/mass spectroscopy, and to measure biomarker/biologics and antibody immunogenicity using immunochemistry.
In the FDA review, which took place between March 23 and March 27, the entire BAS facility was inspected and two bioequivalency (BE) studies were audited. The State Food and Drug Administration (SFDA) of China sent four investigators to participate as observers.
"We are very pleased to have passed this audit," commented Dr. Ge Li, Chairman and Chief Executive Officer of WuXi AppTec. "It represents our company’s first audit by U.S. FDA and the first such audit of any bioanalytical laboratory in China. WuXi will continue to pursue the highest levels of quality and transparency to meet and exceed FDA requirements."
"As a GLP-compliant facility, BAS always treats quality and compliance as our highest priorities," commented Dr. Jinsong Xing, Executive Director of BAS of WuXi AppTec. "We maintain GLP readiness through continuous training, review of technology, and rigorous proficiency testing. Our quality control team thoroughly reviews all data and closely monitors the facility for compliance on a daily basis."
"Quality is our watchword, and continuous improvement in quality is the foundation of our success," echoed Mr. Robert Coldreck, Vice President of GLP Quality Assurance of WuXi AppTec.
About WuXi PharmaTech and WuXi AppTec
WuXi PharmaTech (NYSE: WX) is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech’s services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXi PharmaTech’s operating subsidiaries are known as WuXi AppTec. For more information, please visit: http://www.wuxiapptec.com .
