OUR SKILLS
We recognize the underlying importance of minimizing our environmental impact, reducing energy consumption and developing effective waste-disposal management plans. All processes and utility systems are designed to provide quality and reliability, including water provision (vital to pharmaceutical facilities) and waste water recovery systems.
Environment in site and plants is monitored on a regular basis, as well as occupational health and safety protection. In addition, Fidia Farmaceutici is regularly inspected by worldwide health authorities and subject to internal and external audit procedures, to ascertain that satisfactory quality standards are achieved. Fidia is able to provide a complete production process, from the raw material to packaging of the finished product, guaranteeing that all steps are overseen with the same scrutiny and carefully validated:
Environment in site and plants is monitored on a regular basis, as well as occupational health and safety protection. In addition, Fidia Farmaceutici is regularly inspected by worldwide health authorities and subject to internal and external audit procedures, to ascertain that satisfactory quality standards are achieved. Fidia is able to provide a complete production process, from the raw material to packaging of the finished product, guaranteeing that all steps are overseen with the same scrutiny and carefully validated:
- regularly inspected by the Italian Medicines Agency (AIFA) and international health authorities, such as the US and Korean Food and Drug Administration, the Brazilian ANVISA and G-MED Notified B
- in compliance with the strictest national and international regulation systems and the highest safety standards, such as Quality Assurance ISO 90001:2015 and ISO 13485:2016, EU and US cGMP, including 21 CFR Part 211 and Part 820, a prerequisite to manufacture and export medical devices for the US market.
- CEP certificate R0-CEP 2017-220-Rev 00 for Sodiuam hyaluronate from fermentation for cutaneous and parenteral administration, including intra-articular administration, and for intra-ocular use.
