FDA has recently released guidelines for its Process
Analytical Technology (PAT) initiative. 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."
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. This includes a number of
important univariate and multivariate techniques, including:
1. Partial Least Squares (PLS) - heavily used for
chemometric calibration and construction of multivariate
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
5. Neural Network Classifier - for use in
classifying attribute data based on multiple
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