A Drug Quality System for the 21 st Century:Process Analytical Technology (PAT) a Framework for Scientific Risk-Based Regulation of Pharmaceutical Quality

摘要

FDA oversees the quality of drug products using a two- pronged approach involving review of information submitted in applications as well as inspection of manufacturing facilities for conformance to requirements for current Good Manufacturing Practice (Cgmp). These two programs have served the country well by helping to ensure the quality of drug products available in the US. Now, as we approach the 25 th anniversary of the last major revision to the drug CGMP regulations, it is time to step back and evaluate the currency of these programs so that: (1) the most up-to-date concepts of risk management and quality systems approaches are incorporated while continuing to ensure product quality; (2) the latest scientific advances in pharmaceutical manufacturing and technology are encouraged; (3)the submission review program and the inspection program operate in a coordinated and synergistic manner; (4) regulation and manufacturing standards are applied consistently; (5) management of the program encourages innovation in the pharmaceutical manufacturing sector; and (6) FDA resources are used most effectively and efficiently to address the most significant health risks. This presentation will discuss various elements of a new FDA draft guidance entitled "PAT- A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance. The draft guidance is part of the Agency's August 2002 initiative, and is intended to facilitate progress to the desired state of pharmaceutical manufacturing described in this presentation.