SHANGHAI, Nov. 8, 2010 /PRNewswire-Asia/ — WuXi PharmaTech
(NYSE:
WX), a leading 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.
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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, c
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