The initiative
PAT means „Process Analytical Technology“ and was launched as a FDA initiative in 2002. PAT is a system for better understanding and control of pharmaceutical production processes. FDA´s vision is risk based monitoring of processes, e.g. by intelligent sensors in closed loops, and GMP compliant documented control routines including real time release. The initiative is part of FDA activities for drug quality increase in this decade ( „Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century”).
The current FDA Guidance „PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance“ issued on September 2004 describes a new approach of pharmaceutical production and quality control. Most important for PAT implementation is process understanding and efficient control of pharmaceutical production processes.
FDA´s organisational basis für PAT promotion and support consists of PAT Subcommittee, Steering Committee, several PAT Inspection Teams as well as PAT Research Team and the Policy Development Office.
Our service
Valicare as a service supplier for pharmaceutical industry watches all PAT activities worldwide. By our interdisciplinary team work and risk based project management we are able to support our customer with excellent know-how. Our service covers project planning and design, execution, statistical evaluation and complete documentation according to (c)GMP regulations.
Valicare support