Emil Pharmaceutical Industries Private Limited — EU GMP NCR (EudraGMDP) Findings

An initial onsite GMP inspection was conducted, to assess compliance with EU GMP guidelines. During the onsite inspection, the inspectors observed 4 Critical, 11 Major and a total of 14 Other issues. Inadequate cross contamination measures, lack of good documentation practices leading to data integrity and traceability issues and inadequate packaging operations which were leading to mix ups were of critical concern. Major issues were related to ineffective training, lack of validation studies and control in production, deficiencies in sampling areas as well as in dispensing areas and storage areas, inadequate batch review and release processes, lack of sample and microbiology control and inadequate complaint handling. 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.