Legacy Pharmaceuticals Switzerland GmbH — EU GMP NCR (EudraGMDP) Findings

Swissmedic is updating the NCR as the situation has changed since the NCR has been issued. Legacy Pharmaceuticals Switzerland GmbH has filed for insolvency early December 2020 and is closed. Swissmedic has withdrawn the manufacturing licence with effect December 31, 2020. Swissmedic has issued a NCR on the 30.09.2020 related to the manufacture of sterile products after during a Swissmedic inspection performed on August 27th - 28th, 2020, 5 critical , 14 major and 6 other deficiencies were identified. the deficiencies included: - insufficient control over the air quality of clean rooms; - incomplete qualification of the air handling system of some of the clean rooms; - incomplete validation of sterile filtration operations of aseptically manufactured products; - inadequate frequency of media fill (less than 2x/year) on some of the production lines; - deviation occurring in the context of media fills were not closed in a timely manner (note, however, that the deviations did not concern turbidity); - inadequate deviation management - quality maintenance and qualification status of equipment is not stat of the art. Action taken/proposed by the NCA: Revocation of the marketing authorisation(s) Marketing authorisation holders of products that have been manufactured by Legacy Pharmaceuticals Switzerland GmbH should check if there is a need to request GMP-relevant documentation on their products from Legacy, and/or retention/reference and stability programme samples should be transferred. Recall of batches already released Swissmedic will initiate a recall of all batches of sterile products that are on the Swiss market, with the exception of products that are critical due to its therapeutic use and/or availability of alternatives.