The inspection included a comprehensive review of the quality management system, the manufacturing & QC equipment and facilities
WuXi STA, a subsidiary of WuXi AppTec, has announced its drug product facility in Wuxi City, China has passed its first pre-approval inspection (PAI) and received a GMP Compliance Certificate from the European Medicines Agency (EMA).
The inspection focused on drug product manufacturing for one of WuXi STA’s partners. During a 5-day remote inspection from November 8 to 12 in 2021, the inspector assessed the compliance of the manufacturing operations against the EU Guideline to GMP.
The inspection included a comprehensive review of the quality management system, the manufacturing & QC equipment and facilities, tablet manufacturing operations and controls, material handling and data management & integrity programs. It was completed successfully with no critical or major observations, the company says, and the site can now start to provide commercial drug product manufacturing service for the European market.
WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms. In 2020, the site passed PAI from China NMPA and this latest successful PAI from the EMA further demonstrates the company’s robust and reliable quality system.
Dr Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA, said: “I am very pleased that after our Shanghai Waigaoqiao site passed its first drug product PAI by the US FDA last year, our Wuxi City site has also successfully passed its first drug product PAI from the EMA. We will continue to maintain the highest global quality standards and through our global R&D and manufacturing network, empower more partners to accelerate the development of their innovative medicines for patients worldwide.”