Implementing a PAT Strategy

March 24, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Implementing a PAT Strategy

Many companies want to implement process analytical technology (PAT) in theirmanufacturing lines to better understand their processes, but there are no establishedbest practices for doing so. During the March 21 session, “Establish andImplement a PAT Strategy,” Connie Langberg Heinze, manager of PAT Centerof Excellence at NNE, Inc. (Soeborg, Denmark, discussed what ittakes to implement PAT and recommended a step-by-step strategy for companiesto follow.

According to Heinze, a common pitfall for PAT implementation is that companies buy a new analyzer for PAT and then decide how to use it in their processes. But to best integrate PAT into processes, “You need to know what you’re looking for and how you want to use [the analyzers,]” she said. Ideally, Heinze noted, it’s best to implement PAT on new processes to “give you the full benefit of PAT and less regulatory burden,” although PAT principles also can be extended to existing systems. In all cases, following a clear implementation plan is the best way to define how and why to bring such technology on-line.

Heinze recommended a seven-step implementation methodology: organize a core PAT team, identify opportunities for improvement with PAT, define a pilot project, investigate possible PAT applications, define control strategies and prepare an implementation plan, communicate with regulatory bodies, and implement PAT.

Discussions about how and why to implement PAT is a vital part of PAT implementation. These discussions should involve cross-functional teams comprising of representatives from several departments (e.g., quality control, development, and manufacturing), and input from all team members should be obtained. “Spending days together talking is a productive and easy way to start PAT implementation,” said Heinze.