The European Medicines Agency (EMA) is withdrawing the license of Taiwan-based Savior Liftec after the discovery of serious Good Manufacturing Practice (GMP) non-compliance after an inspection conducted earlier this month.
According to the EMA, the scope of this statement of non-compliance is limited to medicinal products considered non-critical to public health. The inspection identified a critical deficiency relating to the aseptic processing of Meropenem and Meropenem/Sodium Carbonate blend. The deficiency related to a lack of technical knowledge regarding sterile processing and included elements such as, autoclave and dry heat sterilization of equipment, inadequate VHP load pattern design and application, media fills and environmental monitoring.
As a result of the GMP non-compliance the EMA has issued a statement of non-compliance and restricted GMP certificate to permit continued manufacture and testing of sterile API considered to be medically critical or to ensure continuity of supply, as determined by the national competent authority. No batches of non-critical product will be supplied to EU markets whilst this statement of non-compliance remains in force. There will however be no recalls of product already released.