Quality Compliance

SM Farmaceutici considers quality as a central and essential element of its business.

The main goal of the company is to continuously increase the quality controls and the controls on the production process by using advanced methods and tools in order to offer a more safe and competitive products.All processes and activities are validated and carefully checked, all equipment is continually monitored and subjected to strict controls.

SM Farmaceutici production plant has a GMP compliance history which started more than 40 years ago. The plant is regularly audited by AIFA/EMEA and US FDA without any remarkable deviation. The plant is registered as production site in France, Germany, UK, Portugal, Spain, Belgium, Australia, South Africa, Holland, Poland, Roumania, South America, North America, Middle East and is going to be registered in all North Africa Countries.

Thanks to the high quality standards , the SM plant has the GMP Certification for a large number of products

CertificationsIssued by
GMPItalian Agency (AIFA)
UNI EN ISO 9001 : 2015TUV
EN ISO 13485 : 2016TUV

Production of Large and Small volume I.V. Solutions for Human use
Production of Large and Small volume I.V. Solutions for Veterinary use
Production of corticosteroid solutions for external use in bag
Production of Large and Small volume I.V. Solutions for Clinical Trials
Production of Haemofiltration, Haemodialysis, Haemodiafiltration, Priming, Irrigation solutions

Products with CE Mark
Potassium correctors, Citrate Solutions for HDF, Bicarbonate Solution for HDF in double chamber bags.