Process Analytical Technology (PAT) Implementation Checklist

Design and Process Understanding

Establish the scientific basis for PAT.

• Are critical quality attributes and critical process parameters identified to define what the PAT tool must measure? *
• Is the PAT approach linked to an established design space and control strategy? *
• Is the measurement mode (at-line, on-line, in-line) justified for the process step? *
• Select the primary PAT analyzer technology deployed.

Analyzer and Model Validation

• Is the analyzer (e.g., NIR, Raman) qualified for the intended process environment? *
• Are multivariate calibration models developed with representative calibration and validation data sets? *
• Is a model maintenance and lifecycle management procedure in place for drift and updates? *
• Are outlier detection and model performance monitoring defined? *

Control and Data Integrity

• Is the PAT system integrated with process control to enable feed-forward or feedback control where intended? *
• Do PAT data acquisition and storage meet data integrity and Part 11 requirements? *
• Are audit trails maintained for model changes and control actions? *

Real-Time Release and Governance

• Where PAT supports real-time release testing, is the approach approved in the regulatory filing? *
• Is a fallback control strategy defined for PAT analyzer failure? *
• Is PAT performance included in continued process verification and management review? *