What are some advantages of Process Analytical Technology (PAT) in cleaning when transitioning from the lab to online? Process Analytical Technology (PAT) guidance is a nonbinding FDA document that aims to encourage innovation in cGMP manufacturing. The key advantage of PAT is building quality into products. This is accomplished with robust design, reliability, and ease of use. Advantages of PAT allow for quality by design, demonstrated validation, process understanding, and process control. Understanding and controlling a cleaning validation program means identifying all variables, managing those variables from the process itself, and accurately and reliably predicting important quality attributes. From there, the process can be controlled and adjusted to maintain a desired, validated state. Programs that demonstrate a high degree of process understanding and control have inherent quality gains. Understanding the process life cycle is important and allows for continuous improvement and data collection. These data can then be used to justify post-approval changes, troubleshooting, or optimization.
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