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Process Analytical Technology (PAT)

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:

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.

For more information on PAT, visit: http://www.fda.gov/cder/OPS/PAT.htm.

 

 

 

 

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