Thus the question arises what is specific for managing the quality of biotech derived products ? First of all for the major part of the industry production and QC is outsourced to specialized contract manufacturers, with their own QM-systems and multiple cooperation partners. Major importance therefore has to be given to the Quality Assurance Agreement, describing the responsibilities of each involved party. As the manufacturing competence of the authorisation holder very often is quite limited, the evaluation of a potential cooperation partner has to be performed very carefully, transferring as much responsibility to the manufacturer as possible, but keeping core competencies inhouse.

Secondly quality testing of biological products requires specific techniques and knowhow.Variability of the methods is significantly higher compared to small chemical molecules. Clear decisions have to be taken regarding the amount of tests to be repeated, requiring careful lab to lab validation as well as mutually agreed "out of specification" procedures. Finally biological products (also dosage form dependent) cause significant more technical as well as drug safety related complaints, therefore requiring highly effective complaint handling and medical surveillance systems. Based on our own experience classical chemical as well as biological products can be managed in a common QM-system, however for biotechnological products the complexity to safeguard an adequate market supply is significantly higher.This complexity requires an even more effective QM-system, keeping in mind that "less can be more".

Dr. Thomas Wozniewski