8:00 a.m. – 11:30 a.m., US ET
USP General Chapter <1037> Process Analytical Technology – Theory and Practice has been published in USP’s Pharmacopeial Forum on May 1, 2025, for public comments. The objective is to establish a comprehensive guide that aligns with current scientific and regulatory standards, providing clear direction for the implementation of Process Analytical Technology (PAT) within pharmaceutical companies. This chapter serves as a comprehensive guidance on PAT, ensuring the continued advancement and quality of pharmaceutical manufacturing. The new chapter on PAT will contain but not be limited to the following topics:
- Introduce newly proposed PAT chapter <1037> Process Analytical Technology – Theory and Practice: Prospectus
- PAT definition and its core attributes
- Enablers I: Instrumentation and chemometrics in PAT
- Enablers II: Life cycle management of PAT
- Enablers III: An overview of the regulatory landscape
- Use Cases: Emerging trends and technologies in PAT
In addition to Chapter <1037>, two Stimuli articles - one on Theory of Sampling in PAT and the other on Implementation of Real Time Release Testing - will also be discussed. This webinar will further introduce other related PAT initiatives at USP, including the USP Pharmaceutical Continuous Manufacturing Technical Guidance, an Overview of the USP Advanced Manufacturing Technology Laboratory, and USP Pharmaceutical Continuous Manufacturing Knowledge Hub.
This webinar is an online event, free for public registration. The webinar includes a presentation followed by Q&A.
Contact Information:
Yang Liu, Ph.D.
USP Compendial Science
General Chapters
Yang.liu@usp.org
For further information or to suggest additional stakeholder topics related to USP General Chapters please contact us at gc@usp.org.