WuXi PharmaTech, a pharmaceutical, biotechnology and medical device research and
development outsourcing company with operations in China and the United States,
today announced that it had been awarded a Certificate of Good
Laboratory Practice (GLP) compliance from the State Food and Drug
Administration (SFDA), China’s
regulatory authority for pharmaceuticals, for its toxicology facility in
Suzhou. 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 certification covers single-dose and multiple-dose toxicology
studies in both rodents and non-rodents, GeneTox studies (Ames,
micronucleus, and chromosome aberration), and toxicokinetic studies.
WuXi qualified for this certification as a result of SFDA review of its
management, personnel, test facilities, standard operating procedures,
and study operations. Receipt of this certification is necessary in
order to perform toxicology studies to be filed in Investigational New
Drug (IND) applications with the SFDA.
In September, WuXi announced that the Suzhou facility had received
GLP certification from the Organization for Economic Cooperation and
Development. WuXi’s Suzhou facility is the only toxicology facility in China to have received certification from both the SFDA and OECD.
“This certificate from the SFDA is an important milestone in offering
our clients toxicology studies that meet both domestic and
international GLP quality standards for filing INDs both in China and other countries,” 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 pharmaceutical and
biotech clients a comprehensive, fully integrated platform of
pharmaceutical R&D services.”