Type of Notice: General Chapter Prospectus
Posting Date: 29-Mar-2024; revised 01-Apr-2024
Input Deadline: 28-Apr-2024
Background and Objectives
The United States Pharmacopeia (USP) is preparing to introduce a new general chapter (> 1,000) dedicated to Process Analytical Technology (PAT). The objective is to establish a comprehensive guide that aligns with current scientific and regulatory standards, providing clear direction for the implementation of PAT within pharmaceutical companies. This chapter will encapsulate the definition, core attributes, key enablers, and practically applied and modern uses of PAT, with a focus on its timeliness, sampling relevance, regulatory implications, analytical measurement integration, and the production of process- and product-relevant attributes, including Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
Description of Scope and Application
The proposed chapter will outline the background and practical applications of PAT in the pharmaceutical industry. It will provide guidance on the integration of PAT systems within pharmaceutical processes, ensuring that the technology is leveraged effectively for real-time monitoring and control, process validation, and verification, as well as product quality assurance and release. 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.
Preliminary Outline
The new USP chapter on Process Analytical Technology will contain but not be limited to the following topics:
- INTRODUCTION – This section will introduce the concept of PAT and its significance in the pharmaceutical industry. It will discuss the evolution of PAT and its critical role in enhancing product quality and manufacturing efficiency.
- DEFINITION AND CORE ATTRIBUTES OF PAT – A detailed definition of PAT will be provided, along with an exploration of its core attributes. This section will emphasize the necessity of timeliness, sampling relevance, regulatory implications, analytical measurement technology, integration, and the relevance of process and product attributes.
- KEY ENABLERS OF PAT – This section will discuss the various enablers that facilitate the effective use of PAT, such as sensors, analyzers, data-driven modelling (including chemometrics, machine learning, and AI), process automation, IT system integration, automated sampling technology, Design of Experiments (DOE), and risk assessment methodologies like Failure Mode and Effects Analysis (FMEA).
- REGULATORY CONSIDERATIONS – An overview of the regulatory landscape will be presented, highlighting how PAT aligns with current guidelines and standards. This section will discuss the implications of PAT on regulatory submissions and compliance.
- IMPLEMENTATION STRATEGIES – Guidance on implementing robust PAT applications in pharmaceutical manufacturing facilities will be provided. This includes strategies for integrating PAT tools with existing systems, data management, and the use of PAT in process development, scale-up and manufacturing.
- APPLICATIONS OF PAT – Case studies and examples of PAT applications in continuous process verification, continuous manufacturing, control, validation, quality assurance and RTRT will be presented. This section will cover a range of pharmaceutical modalities, including small molecules and biologics.
- EMERGING TRENDS AND TECHNOLOGIES – The chapter will conclude with a look at emerging trends and technologies in PAT, discussing potential future directions and innovations in the field.
This prospectus serves as an invitation to the pharmaceutical community to anticipate the comprehensive guidance that the new USP chapter on Process Analytical Technology will provide, ensuring the continued advancement and quality of pharmaceutical manufacturing.
Anticipated proposed design phase activities: USP is requesting early input from stakeholders on this potential proposed General Chapter <1037> which is anticipated to be published for comment in the Pharmacopeial Forum.
Contact: Yang Liu, Senior Scientist (yang.liu@usp.org)
This notice was revised on April 1, 2024 to provide contact information for comments and inquiries.