USP: Comments possible on the Topic "Process Analytical Technology"

The new general chapter "<1037> Process Analytical Technology-Theory and Practice" and the two related stimuli articles "Process Analytical Technology I-Theory of Sampling in PAT" and "Process Analytical Technology II-Implementation of Real-Time Release Testing" of the USP have been published on the website of the Pharmacopeial Forum for comments. Comments on these drafts can be submitted until 31 July 2025.

<1037> Process Analytical Technology-Theory and Practice

The new general chapter consists of the following points:

• Introduction
  o Definition of Process Analytical Technology
  o Integration of Quality by Design and PAT
• Key Enablers and Implementation Strategies
  o Instrumentation for PAT
  o Chemometrics
  o Collection of Spectra for In-Line Spectroscopy Models
• Life Cycle Management
  o QbD and PAT
  o Design and Development
  o Implementation, Monitoring and Control
  o Method Verification, Revalidation and Continuous Improvement
  o Method Rebuilding (Recalibration)
• Regulatory Considerations
  o Quality Control Unit
    I. Training of Manufacturing Personnell
    II. In-Process Testing (Process Validation)
    III. Scope of Part 211
• Emerging Trends and Technologies
  o Imaging
  o Automated Sample Handling
  o Multiple PAT Tools for Integrated Processes Control
  o Timely Measuring Advances
• References
• Glossary

Process Analytical Technology I-Theory of Sampling in PAT

This stimuli article highlights the importance of sampling as an integral part of Process Analytical Technology (PAT) and shows that both PAT and TOS (Theory of Sampling) must go hand in hand to achieve the desired results.

Process Analytical Technology II-Implementation of Real-Time Release Testing

The second stimuli article on Process Analytical Technology explains the interaction of "Real-Time Release Testing (RTRT)" with PAT.

You can view and comment on the drafts of chapter <1037> and the two Stimuli articles after registering once on the Pharmacopeial Forum website.