Ilko Ilac Sanayi Ve Ticaret A.S. — EU GMP NCR (EudraGMDP) Findings

An onsite GMP inspection was conducted following an application received by the company, to assess compliance with EU GMP guidelines. During the onsite inspection, the inspectors observed 1 Critical, 4 Major and a total of 19 Other issues. Significant data integrity gaps in the QC laboratory were of critical concern, demonstrating a failure to ensure traceability, security, and control of electronic data. Major deficiencies were related to inadequate OOS management, and insufficient controls for sampling, testing, and outsourced testing. Further major concerns were related to poor cross-contamination controls, deficiencies in manufacturing operations and non-compliant temperature mapping of storage areas. 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: Suspension of the marketing authorisation(s) Member states should consider whether the status of any ongoing marketing authorisation applications should be reviewed until the statement of non-compliance remains in place. Action against affected MAs should be considered where potential quality defect has greater impact to public health than supply restriction in affected Member State(s).