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Solutions for PAT (Process Analytical Technology)

In 2003 the US Food and Drug Administration published its draft document ‘Guidance for Industry: PAT-a framework for Innovative Pharmaceutical Manufacturing and Quality Assurance.’ In this draft guidance, the FDA has made it clear that it believes that PAT should help manufacturers develop and implement new efficient tools for use during pharmaceutical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 expected outcome is that the industry will be encouraged by the FDA to adopt innovative technologies to increase quality without concern that a new approach will lead to validation risks and production delays.

Process Analytical Technology and the FDA support for a PAT framework represents a significant breakthrough for the manufacturing aspect of the industry. PAT will usher in a new era in manufacturing of pharmaceutical products and enable the industry to capitalize on innovative technologies to increase quality and reduce costs, in the same way as less regulated industries. As PAT evolves the role of IT will become increasingly important. The FDA itself already points to four categories of IT tools for:

- Multivariate data acquisition and analysis
- Modern process analyzers or process analytical chemistry
- Process and endpoint monitoring and control tools, and
- Continuous improvement and knowledge management

PAT is data intensive and implementation of a PAT program requires a data management environment that is capable of handling the volumes and types of data to be recorded. Read our PAT: Exploring the new philosophy of the FDA whitepaper to learn how RAPID-Pharma can be used as the data management system to capture, warehouse and report on PAT data.