FDA's PAT Guidance as it Applies to Real-Time Testing

摘要

In 2004 the FDA published a guidance document on Process Analytical Technology (PAT). It contains non-binding recommendations and serves to encourage GMP manufacturers to deploy PAT to achieve process understanding, process control, and robust risk management. PAT allows for real-time measurements of desired quality attributes to optimize efficiencies. One of many benefits of obtaining real-time data is process understanding and demonstration of a validated state without manual sampling or laboratory analysis.