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The FDA's "PAT" or Process Analytical Technologies initiative is designed
to improve the quality of pharmaceutical products for the good of
both industry and the public health. To do this, the FDA urges pharmaceutical
firms to apply process analytical chemistry tools, feedback process
control strategies, information management tools, and product/process
optimization strategies to the manufacture of pharmaceuticals. It
also advises firms to develop a program for continuous process verification
or validation and/or quality assurance. PAT is designed to improve
quality problems such as scrap, rework, recall, drug shortages, drug
approval delays, and the high cost of compliance.
Two significant barriers to an effective PAT system are the inability
to identify the critical parameters that cause variation, and the
inability to access the data from disparate databases in a quick,
simple fashion.
To overcome the first barrier, PC&C -- a key element in our PAT approach
-- applies a mixture of formulation, manufacturing and statistical
skills to identify key parameters. To overcome the second, PC&C uses
a data integrating and reporting system called Pharma+Pro, that is
validatable and available on numerous company desktops, so that process
performance can continually be monitored. As a result, PC&C significantly
outperforms "software alone" or "man-in-the-plant" short-term remedies.
The approach is also quick to implement and easy to sustain. |
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