Yung Shin Pharm. Ind. Co. Ltd. — EU GMP NCR (EudraGMDP) Findings

During the inspection of Yung Shin Pharmaceutical Industry Co. Ltd., there were 2 major concerns: 1. the sterility of the drug cannot be guaranteed, and 2. the risks of cross-contamination are insufficiently known and managed. The following issues were identified: - In relation to the aseptic process: The firm accumulates several deficiencies related to the aseptic processing, for instance it does not correctly address the filling line set up assembly (lack of aseptic connectors and aseptic sampling port), nor the particular configuration of the booth housing the filling tank (first air concept not taken into account). In addition, the aseptic process simulation needs to be improved as well as the sterilization of : materials, filling lines and equipments. None of these elements are assessed in the CCS (Contamination Control Strategy). - In relation to cross-contamination: It was found that the plant also manufactures other drugs including corticoids. However, the ADE values of the APIs are not known, a risk analysis of the cross-contamination risks and a cross-contamination prevention strategy based on it are missing. Action taken/proposed by the NCA: Others Amphotericin B manufactured at Yung Shin Pharmaceutical Industry Co. Ltd.is currently not imported to the EU market and the site does not hold a MIA nor a GMP certificate. No action is required.