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|Articles|October 29, 2019
WuXi STA Announces Successful EMA Inspection of Jinshan Facility
Author(s)BioPharm International Editors
The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan’s Pharmaceutical and Medical Device Agency for an innovative drug.
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STA Pharmaceutical Co. (WuXi STA), a subsidiary of WuXi AppTec, announced its Jinshan manufacturing facility in Shanghai, China, passed an inspection by the European Medicines Agency (EMA) on Oct. 28, 2019.
“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. 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.” said Mei Hao, vice president of Quality at WuXi STA, in a company press release.
The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan’s Pharmaceutical and Medical Device Agency for an innovative drug, according to a company press release. The facility is also on track to become the second site to support process R&D and manufacturing of APIs with a new API process R&D center that will add 30,000 square meters of laboratories and over 800 scientists to the facility.
“The successful EMA inspection at Jinshan is yet further proof of WuXi STA's commitment to enforcing the highest global quality systems. 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,” said Dr. Minzhang Chen, CEO of WuXi STA, in the press release.
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