Process Analytical Technology
The 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."
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. This includes a number of important univariate and multivariate techniques, including:
- Partial Least Squares (PLS) - heavily used for chemometric calibration and construction of multivariate statistical models.
- Principal Components Analysis (PCA) - used to reduce dimensionality when many factors are involved.
- Multivariate T-Squared and EWMA Control Charts - for controlling processes with correlated variables.
- ARIMA Control Charts - for controlling dynamic manufacturing processes.
- Neural Network Classifier - for use in classifying attribute data based on multiple quantitative measurements.
- Multivariate Capability Analysis - for determining the capability of meeting specifications based on multiple variables.
- Design of Experiments - construction and analysis of experiments designed to aid in process optimization.
For more information on PAT, visit: http://www.fda.gov/cder/OPS/PAT.htm.
