Quality Management System

The quality system at FAL Duiven is designed to fulfil all appropriate requirements of the E.U. Directive 2001/83/EC as supplemented by 2017/1572/EU and 91/412/EEC and to be in accordance with the rules of the Good Manufacturing Practice, as defined in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines.

Good Manufacturing Practice is recognized to also encompass Good Control Laboratory Practice, Good Distribution Practice, Good Automated Manufacturing Practice, Good Validation Practice and Good Clinical Practice in respect of bioequivalence studies.

For FAL Duiven it is key to provide its customers with products that meet the appropriate criteria of compliance, quality, safety and efficacy. To ensure product quality, not only the quality of materials and products throughout the process need to be controlled, but also the quality of processes of manufacturing, materials handling, distribution, and the factors that influence these processes. Quality of products is achieved through quality of our primary and support processes, all people involved and technologies used in these processes, and the organization of these aspects into a coherent system.

The Quality Management System is an integrated system, based upon a comprehensive documentation system of specifications, standard operating procedures, batch manufacturing and, if applicable, packaging records, being supported by qualified equipment, validated manufacturing process and analytical methods, and trained operators.