From Earlier: WuXi PharmaTech Receives GLP Statement for Suzhou Toxicology Facility

WuXi PharmaTech

today announced that its toxicology facility in Suzhou had received a statement of Good Laboratory Practice (GLP) from the Belgium Scientific Institute of Public Health after successfully passing two GLP inspections conducted by the Belgium GLP Monitorate. 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 statement is an important acknowledgement by a full OECD/EC member monitoring authority about the capability of the Suzhou facility to carry out toxicology and mutagenicity studies and analytical and clinical chemistry testing with respect to OECD and EC principles of GLP. Award of the statement resulted from a four-day inspection conducted by a team of four inspectors from the Belgian national GLP compliance monitoring authority in March 2012. In addition to an extensive facility assessment, the inspection included an audit of 16 studies in areas that included general toxicology, genetic toxicology, safety pharmacology, dermal irritation, skin phototoxicity, 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. The facility successfully passed an earlier inspection in 2010. In November 2010, WuXi announced that it had received a certificate of Good Laboratory Practice from China's State Food and Drug Administration for the Suzhou toxicology facility. "WuXi's receipt of this statement is further acknowledgment that we offer our pharmaceutical and biotech clients toxicology studies that meet international GLP quality standards," said Dr. Ge Li, chairman and CEO of WuXi PharmaTech. "With this award, WuXi moves a step closer to achieving its goal of offering our clients a comprehensive, fully integrated platform of pharmaceutical R&D services."