Process Analytical Technology (PAT)

FDA expects both examination of material quality and equipment monitoring. PAT can be involved into those processes and control loops allow adjusting processing conditions so that the output remains constant within defined operational limits. Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA). The PANDA system supports in a comprehensive way the display of all relevant information.

A whole well-integrated PAT tool box like spectroscopic tools or sensors of all kind is available and routinely used on all levels of production like treatment of raw materials, intermediates and drug substances. Qualitative trending as well as quantitative determination of the components of interest is performed continuously and in a specific way so evaluation occurs in real time.

PAT tools and concepts in development are similar to those used in production, but not necessarily the same. The vast majority of PAT tools and “real time or in-situ” applications support the development and understanding of processes in a lab-based environment (or in pilot facilities), with few transferring as quantitative measurements and feedback controls into the production plant. The metaphor of an iceberg where the visible PAT activities undervalue the vast base that underwrites the knowledge and understanding might be a good analogy.

 

 

Process Design supported with PANDA

PANDA is a flexible system to support the process design phase. CPP data of experimental processes can be captured in different systems like OSI PI or GECCO. Also CQA data can be already available via LIMS systems, via Excel or GECCO. In the process design phase, PANDA supports the responsible users in research and engineering with analysis reports which bring together the influencing process parameters and the resulting product properties. With PANDA system in this stage Critical Process Parameters (CPP) und Critical Quality Attributes (CQA) can be defined and continuously monitored over the whole product lifecycle. Deviations from the design space are easily detected.