Wuxi STA site passes EMA drug product pre-approval inspection
The site is focused on formulation development and manufacturing for a broad range of oral and injectable dosage forms. It passed a PAI from China’s NMPA in 2020, said the contract development and manufacturing organization (CDMO).
The most recent PAI is related to product manufacturing services for a drug for one of WuXi STA's partners.
The company outlined how, during a five-day remote inspection from November 8-12, 2021, the inspector assessed the compliance of the site's manufacturing operations with EU Good Manufacturing Practice (GMP) guidelines.
The inspection included a comprehensive review of the quality management system, the manufacturing and QC equipment and facilities, tablet manufacturing operations and controls, material handling and data management and integrity programs. "The PAI was completed successfully with no critical or major observations," said WuXi STA.
The site, added the CDMO, is now ready to start providing commercial product manufacturing for the drug aimed at the European market.
Since its initial founding, WuXi STA has passed over 50 inspections from all major regulatory agencies including US FDA, EMA, China NMPA, SwissMedic and Japan PMDA.
Notably, the company's Shanghai Waigaoqiao site passed its first drug product PAI by the US Food and Drug Administration (FDA) last year.