fbpx

Certified European quality

Sanitas Farmaceutici is a pharmaceutical company accredited since 22/8/1998 at the Ministry of Health with S.I.S. code 1553 and certified according to UNI-EN-ISO 9001:2015 with a Quality Management System integrated with the Pharmacovigilance System.

Sanitas in compliance with the European Norm carries out a series of Pharmacovigilance activities aimed at the continuous assessment of all information, related to the safety of medicines, in order to ensure a risk/benefit ratio always favorable for the population.

Pharmacovigilance activities apply to medicinal products, authorized by the Italian Medicines Agency (AIFA), and owned by Sanitas.

Our company is continuously committed to maintaining and improving the integrated quality-pharmacovigilance management system in compliance with mandatory requirements, in order to provide high-quality and safe products.

The effectiveness of the System is periodically checked, Internal Audits are conducted by qualified personnel and once a year by an inspector from the certifying body to renew the certificate, all with a view to continuous improvement.

Our manufacturers are all Italian with production plants in Italy, highly qualified, certified, and recognized by the Ministry of Health according to various standards, such as ISO 13485 (MEDICAL DEVICES) ISO 22716 (COSMETICS) ISO 45001:2018 (SAFETY) FDA REGISTRATION and ISO 9001, GMP. GMP certification is a certification of good manufacturing practice, ensuring the integrity of the food production process and compliance with food safety regulations.

For Sanitas, ensuring product safety and quality is a fundamental and priority issue.

The production facilities of our suppliers, following certification, undergo several periodic audits by notified bodies and the Ministry of Health. The audits are very thorough; the facilities, all production procedures, and product analyses are checked to certify that Good Laboratory Practices are implemented. Each production batch is analyzed and checked before being put on the market, always according to current regulations.

QUALITY CERTIFICATE