WuXi PharmaTech, a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, has announced that it has been awarded a Certificate of Good Laboratory Practice (GLP) compliance from the Organization for Economic Cooperation and Development (OECD) for toxicology and mutagenicity studies, conducted at the company's Suzhou facility.
The OECD is an inter-governmental organization in which representatives of 29 industrialized countries in North America (including the United States), Europe, and the Pacific, as well as the European Commission, work together on issues of mutual concern. The OECD has developed Principles of Good Laboratory Practice to promote the quality and validity of test data, used for determining the safety of chemicals and chemical products. Good Laboratory Practice is a quality system concerned with the organizational process, and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.
The certificate recognizes that our Suzhou facility is operating in compliance with OECD Principles of Good Laboratory Practice. Award of the certificate resulted from a one-week inspection conducted by the Belgian national GLP compliance monitoring authority. In addition to an extensive facility assessment, the inspection included an audit of two general toxicology studies and four genetic toxicology studies. The facility inspection evaluated key operational areas, including vivarium rooms, pharmacy, analytical chemistry, clinical pathology, histopathology, and central archive.
"This certificate from the OECD is an important acknowledgment that we now have the capability to offer our clients GLP 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 pharma and biotech clients a comprehensive, fully integrated platform of pharma R&D services."