Chinese CRO WuXI Apptec Completes Three Regulatory Inspections from FDA, OECD & CNAS

Chinese Reg

TrialSite News republishes a WuXi Apptec press release reporting three of WuXi AppTec Laboratory Testing Division’s facilities, Drug Safety Testing, Bioanalytical Services and Medical Device Testing, recently completed regulatory inspections from the US FDA (Food and Drug Administration), OECD (Organization for Economic Co-operation and Development), and CNAS (China National Accreditation Service for Conformity Assessment), all with excellent results.

On February 23rd and 24th, CNAS regulatory inspectors conducted on-site inspections based on ISO/IEC 17025, CNAS-CL01:2018 and CNAS-CL-01-A023 in WuXi AppTec’s new facility in Guoxiang, Suzhou city. This inspection covered medical device testing, including biocompatibility labs, chemistry labs, microbiology labs, and large animal research labs. The inspections focused on facility quality systems and effectiveness, technical competency and capability with on-site experiments, and data comparison. The new Guoxiang facility passed the inspection and received the CNAS accreditation with combination of GLP principle and ISO 17025 system.

On February 25th and 26th, OECD inspectors conducted the 5th GLP inspection on bioanalytical service labs in Shanghai. This GLP inspection covered various aspects including GLP facility operations (including newly expanded immunochemistry labs), quality system management, and selected study audits. WuXi AppTec successfully passed the inspection, and will receive the GLP certificate for the 5th time.  On March 8th, the US FDA (Food and Drug Administration) completed a directed study inspection at WuXi’s drug safety evaluation center in its Suzhou facility with two minor findings. This 5-day GLP inspection covered bioanalytical testing, in-life study, pathology, facility operation quality management system, and data integrity. “We are pleased with the outcome of these three regulatory inspections. Not only does WuXi AppTec provide comprehensive services globally, but we strive to deliver the highest quality in everything we do. Our GLP drug safety and medical device testing services meet global regulatory requirements to support our global clients on regulatory submissions in the United States, OECD countries and China,” said Dr. Steve Yang, Executive Vice President and Chief Business Officer of WuXi AppTec.