Process Analytical Technology - How Can I Keep My Eye On Quality?

The pharmaceutical and life science industries are headed for fundamental changes within the next decade. These changes are due to regulatory, market, scientific and technological developments, just to name a few. Manufacturing efficiency and innovation are in high demand for businesses that wish to secure their competitive position. The concept of Process Analytical Technology (PAT) plays a decisive role within this change.

The development and implementation of PAT in pharmaceutical and life science industries has been clearly defined in a US Food and Drug Administration (FDA) guidance. Topics embraced by the initiative “Pharmaceutical cGMPs for the 21st Century” include ongoing changes in manufacturing technology, the philosophy of product quality control, the drug approval process and the regulatory environment. PAT allows realtime monitoring of product quality and an improved process understanding. It also enables right-first-time manufacturing with a tightly controlled process with quality as an integrated standard in all processes. By reducing the need for trial and error, FDA regulators expect that the implementation of PAT will allow companies to more easily improve manufacturing processes and reduce product development times.