Monitoring and Control Tools for Implementing PAT

istration’s process analytical technology (PAT) initiative is to encourage pharmaceutical manufacturers to improve their operations to reduce the cost of pharmaceuticals. Before the PAT initiative, there was not much emphasis on changing ongoing pharmaceutical operations—repeatability, not innovation, was the order of the day. Now that the regulatory climate has changed, how can pharmaceutical manufacturers look to achieve results? Today’s automation systems can be an excellent place to begin. Technology is now available to automatically evaluate measurement and control performance and point directly to those areas where improvements are possible. Reduction in process variability is one of the key areas that can be influenced by this effort. Imagine the impact on costs if production cycle times can be reduced or a few rejected, out-of-specification lots of material can be avoided by improving operations to ensure that all manufactured goods are made right the first time.