
The origins of PAT trace back to bringing measurements made in the laboratory into the production environment. Consequently PAT was initially interpreted as integrating advanced sensors into manufacturing processes. More recently PAT has grown to mean much more than sensors, as described in the definition by the FDA:
“Process Analytical Technologies are: systems for analysis and control of manufacturing processes based on timely measurements, during processing, of critical quality parameters and performance attributes of raw and in-process materials and processes to assure acceptable end product quality at the completion of the process.”
The FDA has identified four PAT tools for generation of process understanding:
• Multivariate tools for design, data acquisition and analysis
• Process analyzers
• Process control tools
• Continuous improvement and knowledge management tools
Umetrics' contribution
Umetrics presented the concepts of multivariate technology to the Advisory Committee for Pharmaceutical Science at the FDA in 2001 and 2002. ¹ ² Also, Professor Svante Wold of Umetrics was invited by the FDA to assist as a member of the chemometrics working group that reported to the PAT subcommittee. Umetrics unique strength with more than 30 years experience in the field has played an important role in helping to introduce and teach others the usefulness of multivariate technology for PAT applications.
¹ Food and Drug Administration, Advisory Committee for Pharmaceutical Science, November 28, 2001. Link to FDA.
² Process Analytical Technologies Subcommittee of the Advisory Committee for Pharmaceutical Science, February 25–26, 2002. Link to FDA.
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Further reading
PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, Christopher Watts, FDA,
as pdf document (7,1 MB) or as web page.
(Links to FDA)
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