WuXi PharmaTech’s toxicology facility in Suzhou has received a GLP certificate from the State Food and Drug Administration (SFDA) of the People's Republic of China after successfully passing two inspections. Having assessed its processes and conditions under which studies are planned, performed, monitored, recorded, archived, and reported, the GLP certificate acknowledges the facility’s capacity to perform non-clinical lab studies under SFDA GLP regulations.
The inspection included an audit of 16 studies in areas that included reproductive toxicology, carcinogenicity, safety pharmacology, dermal irritation, skin phototoxicity, vascular irritation, and immunology. The inspection also evaluated key operational sites, including the vivarium rooms, pharmacy, central archive, and labs relating to analytical chemistry, bioanalytical services, toxicokinetics, clinical pathology, histopathology, and immunology.
"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," said Edward Hu, chief operating officer and chief financial officer of WuXi PharmaTech. "This award is additional confirmation of WuXi’s capability in offering our pharmaceutical and biotech clients a comprehensive, fully integrated platform of pharmaceutical R&D services."