Process Analytical Technology Working Group

The vision of the Process Analytical Technology Working Group (PAT WG) is to see the benefits of PAT clearly recognized throughout the pharmaceutical industry and by regulatory agencies as well as to encourage the routine integration of these concepts from product development through the product lifecycle when appropriate. The WG’s objectives include publicizing industrial case studies highlighting the scientific basis for and implementation of PAT and developing best practices as an aid to routine and consistent adoption of PAT practices.

The PAT WG is communicating case studies to publicize the degree of acceptance and implementation of PAT within member companies. IQ organized a session at the International Foundation Process Analytical Chemistry (IFPAC, January 2012) on “PAT/RTR Implementation Case Studies.” Five industrial speakers and a FDA representative presented.  On October 15, 2012, IQ and the American Association of Pharmaceutical Scientists (AAPS) PAT focus group co-chaired a session at the AAPS annual meeting on “PAT/RTR Implementation Case Studies-Technical & Regulatory Perspectives.” Three industrial speakers and a FDA representative were present.