Process Analytical Technology Approaches to Risk Reduction through Quality by Design

Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes based on an understanding of the scientific and engineering principals involved and identification of the variables which affect product quality. The primary goal of PAT is to provide processes which consistently generate products of predetermined quality. In so doing, improved quality and efficiency are expected from reduction of cycle times using on-, in-, or at-line measurements and controls, prevention of reject product and waste, real time product release, increased use of automation, and facilitation of continuous processing using small-scale equipment, resulting in improved energy and material use and increased capacity.

Effective PAT implementation is founded on detailed, science-based understanding of the chemical and mechanical properties of all elements of the proposed drug product. In order to design a process that provides consistent product, the chemical, physical, and biopharmaceutical characteristics of the drug and other components of the drug product must be determined. Although the science of analyzing for chemical characteristics such as identity and purity is mature, certain physical characteristics such as solid form, particle size, and particle shape are more difficult to analyze and control. Solid-state chemistry offers a significant analytical framework for PAT implementation. Solid-state methods can be used to investigate the physical properties of the solid, such as particle size, particle shape, stability, ease of drying, filterability, solubility, and dissolution rate, and to develop a manufacturing process that consistently provides the desired form of the API having the desired physical characteristics.

Published by: SSCI Inc.