The PAT initiative urges "systems for continuous analysis and control of manufacturing processes based on real-time measurements." Clearly, the FDA is asking the pharmaceutical industry for a long-term vision for robust product and process reliability. To do this, Tunnell Consulting is implementing integrated approaches that view PAT as a strategic initiative rather than a series of short-term projects. Our structured approach, which can be applied to both new and existing drugs, is thus designed to successfully merge into a company's already developed cultural climate, so that roadblocks to successful implementation are avoided. The five key elements of our integrated strategy are: For more details, click here Step One: Develop a PAT Vision and Strategy Step Two: Define Critical Process Parameters Step Three: Identify and Deploy Analytical Technology Step Four: Create a Data Management Infrastructure Step Five: Ensure Organizational Sustainability