Quality & certifications
Every batch ends up in patients' veins: quality is not a department, it is the way we work. Recognised by independent auditors as an Italian centre of excellence.
GMP
Good Manufacturing Practice for human and veterinary medicines.
FDA
For exports to the United States market.
CE 0373
Authorisation to manufacture medical devices.
ISO 13485
Quality management system for medical devices.
ISO 9001
Quality management system.
ISO 14001
Environmental management system.
BS OHSAS 18001
Occupational health and safety (transitioning to UNI EN ISO 45001).
WHO · PIC/S · ICH
International standards integrated into the quality system for international clients.
Laboratories and quality control
The Monteroni d'Arbia plant has chemical and microbiological analysis laboratories equipped with advanced instruments — including HPLC and gas chromatography — for controls in accordance with GMP, and a Research & Development laboratory in collaboration with the University of Siena.
Batch release and traceability
Every batch is released on the basis of chemical and microbiological testing carried out in our in-house laboratories, with full traceability from raw material to finished product — an essential requirement for anyone producing solutions intended for parenteral use.