Glossary · Automation fundamentals, platforms and components
Process analytical technology (PAT)
Also known as: PAT
German: Prozessanalytische Technologie (PAT)
In pharmaceutical and process manufacturing, process analytical technology (PAT) is a system for designing, analyzing and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality. The term was established by the US FDA's 2004 PAT guidance.
- Automation components
- Process industry
In one sentence
PAT designs, analyzes and controls manufacturing through timely in-line or at-line measurement of critical quality attributes, as framed by the FDA in 2004.
Example
A Raman probe in a granulation line measures the active ingredient content in-line, and the control system adjusts the process before an out-of-specification batch is produced.
How it applies
- Engineering: PAT combines analyzers (for example Spectroscopy such as NIR or Raman spectroscopy (PAT)), multivariate data analysis, process control and knowledge management. The analyzer becomes part of the control loop instead of a lab test after the batch.
- Validation: Analyzers, chemometric models and the software that uses them are GMP-relevant. Their qualification and model maintenance belong in the validation approach, alongside Process validation and ICH Q8(R2) (pharmaceutical development).
- Documentation: Describe what each PAT measurement is used for (monitoring or control decision), its model version and the procedure when the analyzer fails. Operators need to know what happens to the batch if the PAT signal is lost.
PAT supports quality by design; it does not by itself make a process compliant. The regulatory expectations are set by the applicable GMP framework.