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History
The FDA’s Process Analytical Technology (PAT) initiative was put forth to bring pharmaceutical manufacturing
in line with other automated industries. Traditionally, pharma companies have been hesitant to implement innovative
technology for performing quality analysis in the manufacturing process. The FDA has recognized it may be part of
this problem and as a result has put forth the PAT initiative. The goal being to ease pharma manufacturer’s fears
about drawing regulatory scrutiny for using innovative approaches in the development, manufacture, and quality
assurance of new and existing products.
Definition of PAT:
In the words of the Agency, “a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing)
of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring
final product quality.”
Notice the part about timely measurements…
The Goal:
Again, in the words of the Agency, “The goal of PAT is to understand and
control the manufacturing process, which is consistent with our current
drug quality system: quality cannot be tested into products; it should
be built-in or should be by design.”
Read the PAT initiative from the FDA.
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What About the Process?
A key to understanding PAT is appreciating the nuances of the manufacturing process and the role
it plays in quality decisions. This is where the real work of putting PAT into a facility begins.
By knowing these manufacturing processes inside and out, the variability can be understood and then managed.
Manage a Process?
By thoroughly knowing their processes, companies can identify areas for improvement. A variety of tools can then be
applied to design, build, monitor, and produce a product with ever increasing quality and do this consistently through
timely measurements.
Why Timely Measurements?
Using PAT toolkit™ technology, this identification can take place in near-real time and allow quality decisions to be
made instantly in the middle of the process. Traditionally, this quality information may have been known at the end of
the production run when time and resources may have already been wasted.
What’s the Benefit of
PAT?
To list a few…
- Shorter time to market
- Cost savings
- Consistent higher quality products
- More efficient manufacturing
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What reservations do you have about PAT?
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