Process Analytical Technology (PAT) Initiative

The goal of Process Analytical Technology (PAT) is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.

The following is FDA's http://www.fda.gov/ official definition and purpose of Process Analytical Technology (PAT) and how to implement Process Analytical Technology (PAT) to ensure good, safe, and reliable pharmaceutical products to the consumer. For further information about FDA's PAT initiative please access this site http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088828.htm

Process Analytical Technology (PAT) is:

It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.

Process Analytical Technology tools:

There are many current and new tools available that enable scientific, risk-managed pharmaceutical development, manufacture, and quality assurance. These tools, when used within a system can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge. In the PAT framework, these tools can be categorized as:

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

An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance.

The FDA Process Analytical Technology Team can be contacted here:

Office of Pharmaceutical Science, HFD-003
Center for Drug Evaluation and Research
5600 Fishers Lane, Rockville, MD 20857
E-mail pat@cder.fda.gov

Niro Pharma Systems integrate process engineering and PAT to provide Process Intelligence! The FDA's PAT (process analytical technologies) initiative has enabled Niro Pharma Systems to combine its equipment design skills and process engineering know-how in order to integrate online (PAT) analyzers into its process systems in a way which can provide real insight into the operation of the process and help customers achieve key product quality target. For further information about our PAT implementation please contact Mr. Mark Neidlinger (mark.neidlinger@geagroup.com).

Other related pages:

• Real Time Process Determination
• Top and Bottom Spray Fluid Bed Granulation Process
• Lighthouse Probe Technology — Enabling PAT (a link to a PDF document)