Trends in process analytical technology

TLDR

Since the FDA promoted PAT, widespread activity has spread across regulatory agencies, professional societies, academia, and industry worldwide. This review aims to survey PAT‑related developments from 2004 to 2009 and introduce PAT by highlighting advances and convergence across fields. The authors conducted a comprehensive literature review of PAT developments during 2004–2009, summarizing parallel advances and convergence points across various fields and applications. The review identifies five common threads—organizational objectives, enabling sciences, economic outlook, collaborative efforts, and emerging trends—alongside six gaps needing attention, concluding that PAT offers a promising integrated systems approach for quality design, process analysis, and risk‑based management under the FDA 21st‑century GMP initiative.

Abstract

Since the promotion of Process Analytical Technology (PAT) by the U.S. Food and Drug Administration (FDA), there has been a flurry of activities happening across related fields. This excitement permeates regulatory agencies, professional societies, academia and industry worldwide. This review surveys the PAT related developments that have taken place in the period 2004–2009. It serves as an introduction to PAT, with highlights on the parallel advances and convergence points across various fields and applications. From this review, five common threads are identified from the underlying trends of the recent global PAT endeavor, namely, organisational objectives, enabling sciences, economic outlook, collaborative efforts and emerging trends. There are also six potential gaps that require further efforts to bridge. The overall PAT venture is promising for delivering an integrated systems approach for quality design, process analyses, understanding and control, continuous improvement, knowledge and risk-based management within the FDA 21st century pharmaceuticalcGMP initiative.