Process Analytical technology (PAT) als bestandteil des Qualitätsmanagementsystems

PAT (Process Analytical Technology) may be regarded as a further tool amongst all the others, which assures that the quality of a manufactured medicine may be guaranteed. The tool serves the purpose of defining methods for the manufacture and control of the medicine. The basis of these methods is the data obtained during the development and manufacture of a product. These methods allow the process to be thoroughly understood and controlled. Since the publication of the FDAs 21 Century initiative and the Quality System Approach to Pharmaceutical CGMP Regulation in September 2006 system elements are now regarded as an integral part of the Quality Management System. One of these integral parts is the provision of a preventative bias with respect to the maintenance and safety of the quality of a medicine (e.g. Quality by Design). PAT may be regarded as belonging to this kind of element. PAT is used to supervise the manufacturing process for a product or process development in a routine manner by employing the specific introduction of in-process controls and through the use of the knowledge gained from the early development phase of a particular project. Evidence of the amount of quality thereby included the final product may then be reduced. In the planning reference should be taken as to how the new quality element PAT in the form of process understanding is to be introduced to the already established system elements. Furthermore, it should be considered, which advantages PAT may bring and which possible effects it could have on process understanding in combination with the newly established Quality Management System (on the basis of ISO).