For Suzhou toxicology facility
The Chinese State Food and Drug Administration (SFDA) has granted a certificate of Good Laboratory Practice (GLP) to WuXi PharmaTech’s toxicology facility in Suzhou, Jiangsu.
The certification allows WuXi, a pharmaceutical, biotechnology, and medical device r&d outsourcing company, with operations in China and the US, to carry out non-clinical laboratory studies at the Suzhou facility with respect to the requirements of the Chinese Food and Drug Act and SFDA GLP Regulations.
The certificate was awarded following a four-day inspection conducted in March, which included an audit of 16 studies in areas including reproductive toxicology (Segment I and II), carcinogenicity, safety pharmacology, dermal irritation, skin phototoxicity, vascular irritation, and immunology.
The company said 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.
Edward Hu, coo and cfo of WuXi PharmaTech, said the receipt of the certificate is further acknowledgment that the company offers non-clinical laboratory studies that meet national and international GLP quality standards.
‘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.’