Yungshin’s Sterile Injection Plant Was Inspected by British MHRA (the Medicines and Healthcare Products Regulatory Agency)
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2017 / 11 / 20
As a leader in Taiwan’s pharmaceutical industry, Yungshin strives to develop new markets. In addition to passing numerous inspections of TFDA, FDA of the U.S., and Japan’s PMDA, Yungshin’s sterile injection plant received the 5-day on-site inspection of two experts having 20-year experience in sterile injections from British MHRA starting from the 10th of this month. The two inspectors highly recognized the sterile operation, documentation, and operators’ understanding of PIC/S GMP requirements regardless of few minor deficiencies, which, they believed, could be improved by Yungshin. After completing corrective and preventive measures within 3 months, Yungshin expects to receive the PIC/S GMP certification from MHRA and market preparations in EU next year.