10.28.19
STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, said that its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency (EMA) with no critical and no major findings.
“It’s the first time that our Jinshan facility is audited by the EMA, with five auditors conducting a five-day inspection, spanning 11 products approved by the EMA in recent years,” said Mei Hao, vice president of quality, WuXi STA. “We continue to keep up a state of perpetual readiness across all our sites and actively welcome global regulators or client audits at any time. This is a direct testament to our organization’s culture of quality first, and real-time GMP monitoring.”
This quality inspection approval marks a significant year for WuXi STA in exceeding global regulatory standards. In March, the company’s new drug product manufacturing facility in Shanghai Waigaoqiao passed its GMP inspection by the European Medical Products Agency (MPA), and in June, its Jinshan manufacturing facility passed a Pre-Approval Inspection (PAI) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) for an innovative drug. Further, in July, WuXi STA’s Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou passed two inspections by the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.
“The successful EMA inspection at Jinshan is yet further proof of WuXi STA's commitment to enforcing the highest global quality systems,” said Minzhang Chen, chief executive officer, WuXi STA. “We will continue to pursue a ‘quality first’ commitment, constantly enhancing our platform with new services to enable our customers to bring better medicines to patients faster."
Visit Wuxi STA at CPhI booth 80D41.
“It’s the first time that our Jinshan facility is audited by the EMA, with five auditors conducting a five-day inspection, spanning 11 products approved by the EMA in recent years,” said Mei Hao, vice president of quality, WuXi STA. “We continue to keep up a state of perpetual readiness across all our sites and actively welcome global regulators or client audits at any time. This is a direct testament to our organization’s culture of quality first, and real-time GMP monitoring.”
This quality inspection approval marks a significant year for WuXi STA in exceeding global regulatory standards. In March, the company’s new drug product manufacturing facility in Shanghai Waigaoqiao passed its GMP inspection by the European Medical Products Agency (MPA), and in June, its Jinshan manufacturing facility passed a Pre-Approval Inspection (PAI) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) for an innovative drug. Further, in July, WuXi STA’s Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou passed two inspections by the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.
“The successful EMA inspection at Jinshan is yet further proof of WuXi STA's commitment to enforcing the highest global quality systems,” said Minzhang Chen, chief executive officer, WuXi STA. “We will continue to pursue a ‘quality first’ commitment, constantly enhancing our platform with new services to enable our customers to bring better medicines to patients faster."
Visit Wuxi STA at CPhI booth 80D41.
