Earlier today, WuXi AppTec declared that the Organization for Economic Cooperation and Development (OECD) and the European Union (EU) have awarded a Good Laboratory Practice (GLP) certificate to the company’s Bioanalytical Services (BAS) unit.
According to the certificate, WuXi’s BAS facility in Shanghai has been certified and authorized to conduct toxicokinetic and pharmacokinetic studies, ADME (absorption, distribution, metabolism, and excretion) studies, and hERG assay and biomarker studies by adhering to OECD and EU principles of Good Laboratory Practice. The certificate was awarded after Belgian authorities thoroughly scrutinized the operations and records at the facility between May 9 and 11, 2011.
This is third time that WuXi’s BAS has successfully cleared an inspection conducted by regulatory authorities. In March 2009, the facility effectively cleared a bioequivalence study inspection conducted by the US FDA. The facility also completed an audit conducted by China’s State Food and Drug Administration (SFDA) backing the certification of WuXi’s GLP toxicology operation in Suzhou.
The SFDA and OECD have now authorized and certified the BAS laboratory as competent to provide GLP-compliant support for nonclinical studies. The lab has further been certified by the OECD for clinical trials involving small-molecules and biologics, pharmacokinetics, and biomarker analysis.
Established in 2005, WuXi’s BAS is the only bioanalytical laboratory in China to have cleared SFDA, OECD, and FDA GLP inspections. BAS provides GLP-compliant services for the evaluation of small-molecule drugs using liquid chromatography/mass spectroscopy, and quantification of biomarker/biologics and antibody immunogenicity using immunochemistry.
Chairperson and Chief Executive Officer of WuXi AppTec, Dr. Ge Li, said: “We are very pleased to have passed this OECD/EU inspection. WuXi will continue to pursue the highest levels of quality and transparency to meet and exceed international requirements.”
Vice President of BAS of WuXi AppTec, Dr. Jinsong Xing, commented: “As a GLP-compliant facility, BAS always treats quality and compliance as our highest priorities. We maintain GLP readiness through continuous training, review of technology, and rigorous proficiency testing. Our quality control team thoroughly reviews all data and closely monitors the facility for compliance on a daily basis.”