Pharmaceutical manufacturing and the quality by design (QBD), process analytical technology (PAT) approach

摘要

This paper is the result of a literature review focusing on the application of process analytical technology (PAT) for the pharmaceutical industry in conjunction with the quality by design (QBD) framework. PAT and the QBD framework put forward by the FDA, offer a holistic approach to manufacturing pharmaceuticals, emphasising the understanding of process variables on the end products characteristics and transmitting this information upstream to control critical process parameters that effect the critical to quality attributes of a product. Key components of QBD are discussed and their potential impact on current manufacturing processes along with the technological capabilities of PAT and the benefits associated with real-time process monitoring and control.