PAT -A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance 20041214文档.pdf

PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance Ali Afnan, Ph.D. Ali Afnan, Ph.D. Office of Pharmaceutical Science, CDER, FDA Office of Pharmaceutical Science, CDER, FDA FDA/RPSGB Guidance Workshop th 14 December 2004 RPSGB, London, UK What is PAT? An Enabling Framework For innovation in development, manufacturing and quality assurance by removing “regulatory fear/uncertainty” utilizing science risk-based approach to regulatory requirements and oversight providing a flexible and less burdensome regulatory approach for well understood processes creating an environment that facilitates rationale science, risk, and business decisions 2 What is PAT? A system for: designing, analyzing, and controlling manufacturing timely measurements (i.e., during processing) critical quality and performance attributes raw and in-process materials processes The goal of PAT is to understand and control the manufacturing process 3 What is PAT? Scientific principles and tools supporting innovation PAT Principles Process Understanding Risk-Based Approach Regulatory Strategy to accommodate innovation Real Time Release PAT Tools Multivariate Tools for Design, Data Acquisition and Analysis Process Analyzers Process Control Tools Continuous Improvement and Knowledge Management Tools