WuXi Biologics’ Quality Control Department at the Shanghai site (QC-SH) originated from Analytical Sciences (AS) Shanghai. It transitioned to an independent Quality Control Department Shanghai (QC-SH) in December 2017 and supports WuXi Biologics MFG3 manufacturing. Coordinated with AS, MFG3 and Quality Assurance (QA), we provide quality control services for the full process of drug production.
QC-SH focuses on supporting BioDev projects in the clinical phase. We have six functional parts including Physicochemistry, Biochemistry, Bioassay, Raw Material, Microbiology and Environmental Monitoring and Lab Laboratory Operation. We offer services for clients including Method Lifecycle Management (MLCM), raw material spec and release testing, in-process control, DS/DP release testing and stability study, as well as environmental monitoring.
We have state-of-the-art instruments, electronic systems and systemic method lifecycle management. As of August 2020, we have supported over 60 projects, 100 lots production and over 1,000 method qualifications in total. Moreover, we completed audits by 48 global clients including Qualified Persons (QPs) audits and European Medicines Agency (EMA) inspection on Electron Microscopy (EM) labs.