Book by 30 June 2026 and get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
USP plans new Chapter on Process Analytical Technology (PAT)
Recommendation
9-11 June 2026
Development, Validation & Control
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The United States Pharmacopeia (USP) is developing a new General Chapter dedicated to Process Analytical Technology (PAT), aiming to provide guidance on its definition, attributes, enablers, and practical applications in the pharmaceutical industry.
The chapter will focus on aligning with current scientific and regulatory standards, emphasizing real-time monitoring, control, and assurance of product quality throughout the manufacturing process. According to a General Chapter Prospectus published on 29 March 2024, "the scope extends to the use of PAT for process understanding and optimization, including applications in Continuous Process Verification (CPV) and Real-Time Release Testing (RTRT). The chapter will address the regulatory impact of PAT and its role in complying with quality standards."
The preliminary outline is as follows:
- Introduction
- Definition and Core Attributes of PAT
- Key Enablers of PAT
- Regulatory Considerations
- Implementation Strategies
- Applications of PAT
- Emerging Trends and Technologies
USP invites early input from stakeholders on this proposed General Chapter, which is expected to be published for comment in the Pharmacopeial Forum. Comments on the proposed outline are due to the USP by 28 April 2024.
Related GMP News
03.06.2026EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026
03.06.2026FDA Warning Letter: Missing Method Validation - From a QC Topic to a Market-Access Problem
28.05.2026WHO Working Document on Bioequivalence open for Public Consultation
21.05.2026LCGC Article on Analytical Procedure Lifecycle Approaches