WuXi STA yesterday announced that its drug product facility in Wuxi city, China, has successfully passed its first Pre-Approval Inspection (PAI) and received the GMP compliance certificate from the European Medicines Agency (EMA), according to a company statement.
The PAI focussed on the drug product manufacturing of an innovative drug for one of WuXi STA’s partners. During a five-day remote inspection from 8th to 12th November, 2021, the inspector assessed the compliance of the manufacturing operations against the EU Guideline to Good Manufacturing Practice (GMP). 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 programmes. The PAI was completed successfully with no critical or major observations, and the Wuxi City site will start providing commercial drug product manufacturing service of this medicine for the European market, the statement further said.
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, concluded the statement.