Process Analytical Technologies (PAT)
The Process Analytical or PAT initiative is defined as a system for designing, analyzing and controlling manufacturing through timely measurements on the basis of ensuring that quality is ‘built-in’ to the design with the goal of ensuring final product quality. The scientific, risk-based framework outlined in the guidance, Process Analytical Technology or PAT, should help developers and manufacturers implement new efficient tools for use during pharmaceutical development, manufacturing, and quality assurance while maintaining or improving the current level of product quality assurance. The framework includes two components: (1) a set of scientific principles and tools supporting innovation and (2) a strategy for regulatory implementation that will accommodate innovation. The goal of PAT is to encourage developers and manufacturers to take advantage of innovative technological advances in pharmaceutical development, manufacturing and quality assurance, and to improve manufacturing efficiency.
Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and QualityAssurance – This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It is intended to describe a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical development,manufacturing and quality assurance (September 2004).
