Finecure Pharmaceuticals Limited — EU GMP NCR (EudraGMDP) Findings

An onsite renewal GMP inspection was conducted following an application received by the company, to assess continued compliance with EU GMP guidelines. During the onsite inspection, the inspectors observed 1 Critical, 6 Major and a total of 18 Other issues. Significant failures in the quality management system in place and its management at Finecure were observed during the inspection. It was also observed during the inspection a significant turnover of employees since the last renewal inspection. This has resulted in issues with the implementation and maintenance of the quality management system and its continual improvement. A critical finding was observed with respect to quality risk management principles and their application within the organisation. This was also a Major finding in the previous inspection. Major findings were also noted related to Management of personnel and personnel training, Temperature mapping of storage areas and assessment of environmental conditions within the storage areas, Raw material testing and specification, QC Laboratory, Sampling of starting materials and third-party contracted analytical laboratories. As a result of this outcome, the Inspection Review Group (IRG) at the Malta Medicines Authority has met and decided that a Statement of Non-Compliance with the principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 is to be issued for the site. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. MT/050HM/2023 Certificate MT/050HM/2023 will be withdrawn