DEBORA BUZZI*, ALEŠ ŠTRANCAR
*Corresponding author
BIA Separations d.o.o., Mirce 21, SI-5270 Ajdovšcina, Slovenia

Abstract

The importance of the monitoring of a process all along its steps by means of PAT has been defined by FDA in 2002. How can be defined the product quality and what are the parameters that should be checked by means of different analysis techniques, being focused in particular on the application of high pressure liquid chromatography techniques (HPLC) as high value tool for the process monitoring. From the first introduction of Process Analytical Technology to the “state of the art”: how can be PAT implemented in order to ensure the final product quality.

In August 2002, by means of the initiative entitled: "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach", a process oriented towards the introduction of innovation into the pharmaceutical processes has been started. Process Analytical Technology (PAT) initiative is part of this wide process and it was defined within the "Guidance for Industry: PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance", published in September 2004 as follows: "The Agency considers PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality. It is important to note that the term analytical in PAT include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner" (1).

The key point in order to start implementing PAT into a process is the process understanding that pass through the identification of all the critical sources of variability, the management of this variability, through real-t ...