WuXi AppTec Passes FDA Inspection
News Apr 14, 2016
WuXi AppTec has announced that WuXi Lab Testing Division (LTD)’s late-and commercial-stage analytical and stability testing facilities in Shanghai successfully passed an FDA inspection for GMP compliance.
The inspector from FDA China office evaluated WuXi LTD’s quality system during a 4-day inspection, with focus on data integrity and compliance across its GMP analytical and stability testing facilities.
The inspection outcome confirmed WuXi’s adherence to FDA’s rigorous GMP guidance and its high quality of operation.
“FDA expects the highest quality and data integrity, and we are proud to receive a very positive feedback, ”said Dr. Ge Li, Chairman and CEO of WuXi AppTec, “ We will continue to uphold the highest quality standards and provide best-in-class R&D services for our customers worldwide.”
Many life-saving medicines, including insulin, antibodies and vaccines, are derived from living cells. These “biologics” can be difficult to obtain and store on the battlefield or in remote areas. That’s why scientists are trying to develop portable systems that can quickly manufacture small batches of protein therapeutics on demand.READ MORE
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