WuXi's Toxicology Facility Passes FDA GLP Inspection
WuXi PharmaTech, a pharmaceutical, biotechnology, and medical device R&D services company operating in China and the U.S., announced that its Suzho-located toxicology facility passed Good Laboratory Practice (GLP) inspection by the U.S. Food and Drug Administration (FDA).
The company said the inspection was the first of its kind in the toxicology facility’s five years of operation. The FDA surveyed the site for five days and reviewed numerous processes as well as the audit of four studies. The company’s Suzhou toxicology facility has completed more than 90 Investigational New Drug (IND) enabling programs for worldwide regulatory filing.
Dr. Ge Li, Chairman and CEO of WuXi PharmaTech, said, “The outcome of the FDA inspection further demonstrates the consistency of our GLP compliance and quality services following the excellent results of earlier OECD and CFDA inspections.”
The Suzhou toxicology site has also received a statement of GLP from the Belgium Scientific Institute of Public Health on behalf of the Organization for Economic Cooperation and Development (OECD). The Belgium GLP Monitorate conducted three GLP inspections, which the facility successfully passed.
“The Belgian GLP statement for our toxicology facility is a further acknowledgment of the quality of our services, which meet the highest international standards. With this recognition, WuXi has further solidified its leadership in offering the highest-quality toxicology service in China. Toxicology is an important part of WuXi's comprehensive, fully integrated platform of services for our global and domestic pharmaceutical and biotech clients,” said Dr. Ge Li.
GLP is a quality system that assesses the organizational processes and conditions under which health safety studies are planned, performed, monitored, recorded, archived, and reported in a facility.
Earlier this year, the company also announced the construction of a new biosafety testing facility in Suzhou. The facility consists of 38,000 sq ft of laboratories and support areas in a building adjacent to the company’s GLP preclinical drug safety facility. The site’s service offerings will include viral clearance testing and virus/molecular-based safety detection services for both Chinese and multinational customers.