The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance.
The report cites 19 deficiencies, including three critical and 11 major. These findings are based on an Oct. 8 inspection of the Rome site that determined the company does not comply with GMP requirements. Effective Oct. 8, the manufacturing authorization of Iason Italia was suspended by AIFA.
One critical deficiency was due to failure to fully investigate and document out-of-specification results for microbiological environmental monitoring in the manufacture of sterile radiopharmaceuticals. AIFA says the company did not carry out an appropriate and full-scale investigation into the cause of the OOS results.
Another critical deficiency was lack of personnel, as inspectors said there were not enough employees available to conduct all activities necessary for GMP compliance.
In addition, production processes were not controlled in a satisfactory manner, AIFA says. For the manufacture of some batches of the radiopharmaceutical Pcolina, a nonsuitable reagent (expired dibromomethane) was used.
For some radiopharmaceuticals, the regulator also found that master batch documents were incomplete and preparation of the starting material was performed in inappropriate conditions to ensure chemical and microbiological containment.
The company had informed AIFA Oct. 7 that it decided to suspend the manufacturing activities and production of three radiopharmaceuticals: 18F-fludeoxyglucose, 18F-sodium fluoride and 18F- fluoromethylcholine.
The noncompliance report was the third posted in recent months to EudraGMDP, the European database of pharmaceutical manufacturing violations. The others were to GlaxoSmithKline’s China site and to a Cargill facility in France.
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