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Process Analytical Technology (PAT)

What is process analytical technology (PAT)?

Process analytical technology is a methodology used to design, control, and analyze pharmaceutical manufacturing processes. Its main initiative is to measure critical process parameters (CPPs) that directly influence the essential quality attributes of active pharmaceutical ingredients (APIs) and determine how altering these CPPs will affect the process and product.

An important element of PAT is key performance indicators (KPIs), which are well-defined and continually monitored to ensure that the final product’s pre-defined critical quality attributes (CQAs) are consistent.

How does PAT improve healthcare?

PAT is a vital element for the quality by design (QbD) approach, which promotes the need for quality to come from design, not just a test done to a final product. With higher quality products created, PAT helps develop pharmaceuticals that consistently meet quality standards, providing better patient health outcomes.

PAT also reduces the process cost and cycle time, which can benefit the pharmaceutical companies producing the products by cutting extraneous expenses. Additionally, PAT creates a more reliable process that results in successful manufacturing the first time, decreasing the need for re-work.