Akriti Pharmaceuticals Private Limited — EU GMP NCR (EudraGMDP) Findings

A routine onsite GMP inspection of the General Block was conducted, with a focus aligned with the recommendations stemming from the last GMP inspection conducted by Distant Assessment between 21st to 25th February 2022, to follow up on findings and issues identified. The previous inspection by distant assessment had resulted in the identification of 5 major and 22 other issues. During the onsite inspection, the inspectors observed 3 critical, 5 major and a total of 17 other issues, some of which were already identified or not fully addressed and implemented since the distant assessment conducted in February 2022. Ineffective implementation of the quality management system, data integrity issues, and unreliable stability studies were of critical concern, together with lack of control in production and packaging operations including of cross contamination measures and deficiencies concerning analytical testing. 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.