Applying a Structured Methodology to PAT Initiatives

In a recent Pharmaceutical Processing magazine article, PAT Searches for its Identity, author Bikash Chatterjee discusses the seemingly slow pace of Process Analytical Technology (PAT) implementations. The article states:

What the FDA has provided is a bold chance for our industry–long mired in historical inefficiencies and product failure–to reinvent and improve existing processes for superior cycle-time, consistency and yield.

Given the change in regulatory climate the article questions why we haven’t seen a glut of PAT applications to help achieve better operational results. The author points to challenges in the details to implement. Also the traditional emphasis on product and compliance orientation needs to shift as the article states:

…toward an understanding of critical processes to achieve the significant PAT benefits that have worked so well in other sectors.

Given the complexity of this undertaking the author suggests going forward with an approach like Six Sigma as an operational excellence project management framework.

I caught up with Michalle Adkins, a consultant in Emerson’s Life Sciences Industry Center, whom you may recall from an earlier post on five strategies for mitigating project risk. She agrees with the author that a PAT initiative should be managed as part of an overall Operational Excellence program. This is because more structure and process can be provided to the initiative.

Michalle believes that by using the Six Sigma methodology, the right tools can be applied at the right time for evaluating, managing, and implementing PAT projects. The Six Sigma structure of define, measure, analyze, improve, control provides the structure for managing the PAT initiative.

It’s interesting to note that some of the same tools in the Six Sigma toolbox are already inherently part of PAT such as design of experiments (DOE), statistical process analysis, and methods development. These are all very much related in terms of the types of statistical tools that are used.

Given that the PAT guidelines are still relatively new, pharmaceutical and biotech manufacturers are recognizing that the proven Six Sigma tools along with the analytical tools already used for methods development can help organize the PAT process and move these initiatives forward. It will be interesting to see how these PAT implementations begin to accelerate in the coming years as structured methodologies are applied.

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