Process Analytical Technology(PAT)

The FDA has recently released guidelines for its Process Analytical Technology (PAT) initiative and for the use of PAT software. According to the FDA web-site, PAT is:

"a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality."

The goal of Process Analytical Technology 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."

STATGRAPHICS Centurion provides the statistical tools needed to successfully implement PAT. Statgraphics PAT software includes a number of important univariate and multivariate techniques, including:
  1. Partial Least Squares (PLS) - heavily used for chemometric calibration and construction of multivariate statistical models.
  2. Principal Components Analysis (PCA) - used to reduce dimensionality when many factors are involved.
  3. Multivariate T-Squared and EWMA Control Charts - for controlling processes with correlated variables.
  4. ARIMA Control Charts - for controlling dynamic manufacturing processes.
  5. Neural Network Classifier - for use in classifying attribute data based on multiple quantitative measurements.
  6. Multivariate Capability Analysis - for determining the capability of meeting specifications based on multiple variables.
  7. Design of Experiments - construction and analysis of experiments designed to aid in process optimization.
More information about Process Analytical Technology (PAT) is available from the U. S. FDA here and PAT software is available from Statgraphics.