Quality at Auftritt is clearly demonstrated in all phases of the product lifecycle. Quality supervision begins at the test facilities with careful documentation and general conduct of non-clinical safety studies.  This ensures compliance with current Good Laboratory Practice (GLP) and consequently, the integrity of the data produced. Quality supervision then follows through clinical trials, production and distribution, and concludes with shelf-life surveillance.

During clinical stage development, quality supervision guarantees that the fundamentals of Good Manufacturing Practices (GMPs) are consistently applied. Quality is built into the different phases of clinical development to secure:

    The safety and rights of our studies’ participants

    The reliability of the data submitted to health

    Authorities

    The complete adherence to all current Good Clinical

    Practices (GCPs)

Our clinical Quality Management System encompasses clinical research documents, activities and information management systems. Moreover, Auftritt ensures that quality is a main concern, not only in our own processes and procedures, but also in those of our vendors, investigators and contractors who collaborate with us at the clinical stage.

Auftritt has state of the art manufacturing facilities and uses the most advanced testing equipment, to guarantee the quality of our products. Auftritt additionally supervises suppliers' procedures in order to ensure that the highest quality materials are used in our products.

Once a product gains regulatory approval and enters routine manufacturing, quality is guaranteed throughout the process, for both drug substances and drug products.

Manufacturing processes are validated and equipment is tested and certified test methods are confirmed to ensure that each product is of reproducible quality

Continuous improvement practices are employed so that processes and procedures are continually updated.