Fagofarma s.r.o. — EU GMP NCR (EudraGMDP) Findings

The inspection team identified a total of 25 deficiencies: three classified as critical, 17 as major and 5 as minor. Two critical deficiencies concerned the implementation of the pharmaceutical quality system and the knowledge, experience, and number of qualified personnel. The third critical deficiency related to the certification of manufactured preparations and the maintenance of a register of manufactured and certified batches. The principal deficiencies across most areas of GMP involved missing or inadequate records of deviation investigations, change management, training, validation and qualification, documentation management, risk assessment, and stability studies. Critical deficiencies: 1: The pharmaceutical quality system, including good manufacturing practice, is not functional. The system has not been implemented and properly documented, and the monitoring of its effectiveness is not based on real data and quality risk management. Records were either missing or incorrect. 2: The company employs six staff workers. Since the last inspection, three personal changes have occurred in the area of plant management and quality assurance. New employees, in some areas, do not have sufficient knowledge and experience to perform and supervise the relevant activities. 3: The register of manufactured batches is maintained only in an Excel spreadsheet. The inspected entity failed to provide evidence of certification of several batches by a Qualified Person. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. sukls218594/2023 NCR Suspension of clinical trials Suspension of clinical trials (if any) is recommended