Quality management

Fassisi test systems are manufactured in accordance with strict quality and specification standards. This is guaranteed by an audited and comprehensive quality management system which complies with the German Epizootic Diseases Act (Tierseuchengesetz) and the German Medicinal Products Act (Arzneimittelgesetz). All our products are validated and approved by the German Federal Research Institute for Animal Health (Friedrich-Loeffler-Institut – FLI).

 

Fassisi GmbH manufactures its products in accordance with GMP guidelines, thus safeguarding the high quality standards associated with the "Made in Germany" label.

 

Our quality management system is continually being modified and enhanced in line with business developments.

 

Generally speaking, every stage in the development of Fassisi is accompanied by major enhancements to the quality management system. New challenges in the fields of production and development also pose new challenges for our quality management system. New validation procedures, approval criteria and risk management requirements have prompted us to upgrade and consolidate our ambitious quality standards on an on-going basis.

 

We aim to guarantee consistent quality standards and product integrity in the interests of providing our global customers with top-quality products that minimise risks.

 

The quality of our rapid test systems is our top priority. We strive to improve these systems on a continual basis by drawing on current research and technological advances. In the interests of raising standards at Fassisi, we also maintain good relations with our suppliers and run the company in accordance with a well-organised quality management system.

 

Our quality management system is based on the principles of Good Manufacturing Practice. As a manufacturer, Fassisi has established a documentation system based on specifications, manufacturing regulations, processing and packaging instructions, operating procedures and protocols relating to the various manufacturing processes. The documents are kept clear, accurate and up to date. Our entire production system complies with these guidelines and is subject to the current GMP regulations. Our mission is to contribute to animal health on a worldwide basis by means of our innovative rapid test systems.

 

All our rapid test systems have to comply with our quality management criteria irrespective of the law applicable in the country of use. In addition to undergoing our own rigorous approval procedures, all products that fall under the German Epizootic Diseases Act (Tierseuchengesetz – TierSG) are registered and approved by the German authorities. External approval by the Friedrich-Loeffler-Institut is also required for each batch prior to distribution.