USP plans new Chapter on Process Analytical Technology (PAT)

Recommendation

26/27 June 2024
Hamburg, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

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.