Masterstudiengang "Drug Regulatory Affairs"


Impact and Consequences of the PAT Initiatives by FDA and EMEA on New Chemical Entity Synthesis ***

Dr. Dirk Schmidt (Abschlußjahr: 2007)

Process analytical technologies have been applied to manufacturing processes for decades in various industry sectors, e.g. in the food, chemical and oil industry. Recently, the FDA and EMEA have made an approach to implement PAT in drug development and in the manufacturing process.

Employing a scientific and risk-based approach Process Analytical Technology allows timely monitoring and control of critical process parameters which are quality relevant. PAT aims to reduce or completely eliminate the necessity for quality control testing at the end of each intermediate step or at the very end of the process (real time product release). However, the key message is not only the implementation of more in-process measurements to reduce or eliminate existing quality control but to embrace the concept of process understanding, ultimately leading to optimal processes. The PAT concept will, therefore, contribute to shorter product lead-times, a more efficient supply chain and a better use of manufacturing capacity. Given the tremendous advantages of controllable quality for the pharmaceutical industry, there is little doubt that PAT will become a standard tool in pharmaceutical manufacturing within the next years.