Swiss Parenterals Limited — EU GMP NCR (EudraGMDP) Findings

Onsite inspection identified 3 (three) Critical, 12 (twelve) Major and 2 (two) other deficiencies. The Critical deficiencies were related to: 1. The manufacturer failed to minimize risks from contamination associated with the direct human interventions in the critical zone (grade A) during aseptic operations related to the preparation of a sterile blend, and sampling and dispensing of sterile starting materials. Direct human interventions are performed under RLAF without any barrier system. The aseptic techniques/behaviour of the operators were also found not aligned with the requirements; 2. The manufacturer failed to implement adequate aseptic techniques and personnel behaviour, and failed to ensure sterility of disinfectants and garments used in grade A/B manufacturing areas; 3. The Pharmaceutical Quality System was not correctly implemented. A lack of adequate Quality Management oversight, recording, and investigation of all deviations individually or collectively, influences the quality of a product. The inspection team identified failures to ensure that all production deviations are reported, evaluated, and investigated, and the conclusions recorded, as multiple production deviations observed during inspection tours were unaddressed until inspectors informed personnel of the issues. Major deficiencies were found in the following areas: Material transfer in/out of clean areas across all production lines, Production area design and risks related to cross-contamination in Beta-Lactam production, The Contamination Control Strategy (CCS), Procedures for Aseptic Interventions and Aseptic Process Simulation, Cleanliness and maintenance of production facilities, Inadequate gowning and poor personnel hygiene practices, Premises and Equipment in clean production areas and maintenance, Visual Inspection and Container Closure Integrity Testing, Quality Control, Qualifications and Validations, Documentation control, and Computerised Systems. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. 530-10/24-06/08; 381-13-08/310-25-18 Current certificate 530-10/24-06/08; 381-13-08/310-25-18 will be withdrawn. Suspension of the marketing authorisation(s) Member States should consider not authorising marketing authorisation applications/variations to marketing authorisations with this site listed as a finished product manufacturing site until the non-compliance statement remains in place. Recall of batches already released Recall of medicinal products should be considered where potential quality defect has greater impact to public health than supply restriction in affected Member States. Prohibition of supply Following issuance of the final Statement of Non-Compliance with the principles and guidelines of GMP and as long as it remains in place, the prohibition of importation and/or supply from the site should be considered.