Zdrowie i gospodarka · 05/09/2003

Draft Guidance for Industry: Process Analytical Technology - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Guidance for Industry: PAT -- A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance." The draft guidance explains a science-based, risk-based framework, "Process Analytical Technology, or PAT," for developing and implementing innovative manufacturing technology. The guidance is intended to encourage innovative pharmaceutical manufacturing and quality assurance. Working with existing regulations, this guidance also describes a regulatory approach that will enable the agency and the pharmaceutical industry to address technical and regulatory issues and questions anticipated during introduction of new manufacturing and quality assurance technologies.