The Italian Medicines Agency (AIFA) released a non-compliance report on Wednesday for the Rome-based radiopharmaceutical manufacturer Iason Italia with deficiencies linked to quality issues.
AIFA says that based on its inspection from 8 October, Iason does not comply with good manufacturing practice (GMP) requirements.
This is the third GMP non-compliance report posted to one part of EudraGMDP – the European database of pharmaceutical manufacturing violations -- in recent months, with the other two being addressed to Cargill’s French site and GlaxoSmithKline’s China site.
The inspection report includes details on 19 deficiencies identified, including three rated as critical and 11 as major deficiencies.
“The main deficiencies were related to the Quality Management and the Quality Assurance Systems also in terms of sterility assurance and risk of contamination/defects of the final product,” AIFA says.
One critical deficiency was related to failure to fully investigate and document out-of-specification results for microbiological environmental monitoring for radiopharmaceuticals that were intended to be aseptically prepared.
AIFA says the company failed to conduct an appropriate corrective action analysis, and a true root cause was not determined.
“Another critical deficiency was reported with regards to production processes which were considered not satisfactory controlled: it was found that for the manufacture of some batches of the radiopharmaceutical Pcolina (Iasocholine) a non-suitable reagent was used (expired dibromomethane),” AIFA says.
For some radiopharmaceuticals, the regulator also found that master batch documents were incomplete, while the company’s preparation of the starting material was performed in inappropriate conditions to ensure chemical and microbiological containment.
A lack of staffers at the site was also cited as a critical observation.
The remaining major deficiencies were related to specific aspects of the quality assurance system, revalidation and recalibration of critical equipment, data integrity in the context of HPLC management, storage of materials and documentation system.
AIFA says that on 7 October 2015, the company announced the suspension of manufacturing activities and the production of the following radiopharmaceuticals: 18F-Fludeoxyglucose, 18F-Sodium fluoride and 18F-Fluoromethylcholine. The company has yet to respond to a request for comment.