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.