SHANGHAI, Aug. 16, 2012 -- WuXi PharmaTech (NYSE: WX) today announced that its toxicology facility in Suzhou had received a Certificate of Good Laboratory Practice (GLP) from the State Food and Drug Administration (SFDA) of the People's Republic of China after successfully passing two GLP inspections conducted by the SFDA. Good Laboratory Practice is a quality system concerned with the organizational processes and conditions under which health safety studies are planned, performed, monitored, recorded, archived, and reported.
The receipt of this GLP certificate is an important acknowledgement by the SFDA about the capability of the Suzhou facility to carry out non-clinical laboratory studies with respect to the requirements of the Chinese Food and Drug Act and SFDA GLP Regulations.
Award of the certificate resulted from a four-day inspection conducted by a team of five inspectors from the SFDA in March 2012. In addition to an extensive facility assessment, the inspection included an audit of 16 studies in areas that included reproductive toxicology (Segment I and II), carcinogenicity, safety pharmacology, dermal irritation, skin phototoxicity, vascular irritation, and immunology. The facility inspection evaluated key operational sites, including the vivarium rooms, pharmacy, central archive, and laboratories relating to analytical chemistry, bioanalytical services, toxicokinetics, clinical pathology, histopathology, and immunology. This successful inspection now expands WuXi's capability to conduct all non-clinical laboratory studies regulated by SFDA. The facility successfully passed an earlier inspection and received a Certificate of Good Laboratory Practice in 2010.
In May 2012, WuXi announced that it had received a statement of Good Laboratory Practice from Belgium Scientific Institute of Public Health for the Suzhou toxicology facility.
"WuXi's receipt of this certificate is further acknowledgment that we offer our clients non-clinical laboratory studies that meet national and international GLP quality standards," saidEdward Hu, Chief Operating Officer and Chief Financial Officer of WuXi PharmaTech. "This award is additional confirmation of WuXi capability in offering our pharmaceutical and biotech clients a comprehensive, fully integrated platform of pharmaceutical R&D services."
PR Newswire