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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040705/CNM002LOGO )
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 .
For more information, please contact:
WuXi PharmaTech (Cayman) Inc.
SOURCE WuXi PharmaTech (Cayman) Inc.