PAT Evolution and Implementation: Navigating Regulatory Guidelines, and Best Practices for Tool Selection and Validation

Process Analytical Technology (PAT) has evolved significantly since the FDA’s 2004 PAT Guidance, transitioning from a conceptual framework into a cornerstone of modern pharmaceutical manufacturing. Today, a robust and converging regulatory landscape, spanning the U.S. Food and Drug Administration (FDA), International Council for Harmonisation (ICH), United States Pharmacopeia (USP), European Pharmacopoeia, and ASTM International, strongly supports PAT adoption as a key driver of quality, efficiency, and innovation.

Despite this progress, implementation across the industry remains inconsistent, highlighting a persistent gap between regulatory vision and operational reality. The complexity of navigating multiple regulatory frameworks and integrating advanced analytical tools into manufacturing environments presents significant practical challenges.

This presentation provides a roadmap to bridge these gaps by aligning regulatory expectations with practical implementation strategies. It focuses on best practices for PAT tool selection and validation, offering actionable insights to support compliance while enhancing product quality, manufacturing efficiency, and driving innovation in pharmaceutical manufacturing.

Presented by Dr. Farshid Mohammadparast, Process Analytical Technology (PAT) and Chemometrics Principal Investigator at USP

Dr. Farshid Mohammadparast is a Process Analytical Technology (PAT) and Chemometrics Principal Investigator at USP, with a Ph.D. in Chemical Engineering and over nine years of research and industry experience. He leads initiatives and projects focused on PAT and emerging advanced analytical technologies, aiming to enhance pharmaceutical manufacturing efficiency, product quality, and supply chain resilience. He has authored peer-reviewed publications and a book chapter in the fields of chemistry and advanced materials. His expertise spans spectroscopy, imaging techniques, chemometric, AI/Machine learning, and the characterization of both organic and inorganic compounds.

Followed by a live question and answer session

Sponsored by SciY

SciY – Designed to support your digitalization journey, the SciY Digitalization Suite integrates best-in-class technologies and capabilities originally developed by Mestrelab, Optimal, ZONTAL, Arxspan and LOGS, harmonized within the Bruker ecosystem. The vendor-agnostic platform supports life sciences research, development, manufacturing automation and QC functions – with easy-to-integrate, flexible, and user-centric solutions.

For more information, visit www.sciy.com