BRIEFING

 〈1037〉 Process Analytical Technology—Theory and Practice. The General Chapters—Chemical Analysis Expert Committee is proposing to introduce a new general chapter on process analytical technology (PAT). The objective is to establish a comprehensive guide that aligns with current scientific and regulatory standards and provides clear direction for the implementation of PAT within pharmaceutical companies, thus ensuring the continued advancement and quality of pharmaceutical manufacturing. This proposal contains the following key elements:

1. Introduce the concept of PAT and its significance in the pharmaceutical industry. Discuss the evolution of PAT and its critical role in enhancing product quality and manufacturing efficiency.

2. Provide a detailed definition of PAT, along with an exploration of its core attributes. Emphasize the necessity of timeliness, sampling relevance, regulatory implications, analytical measurement technology, integration, and the relevance of process and product attributes.

3. Discuss the various enablers that facilitate the effective use of PAT, including sensors, analyzers, data-driven modeling (including chemometrics, machine learning, and artificial intelligence), process automation, IT system integration, automated sampling technology, design of experiments (DOE), and risk assessment methodologies [such as failure mode and effects analysis (FMEA)]. 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.

4. Detail life cycle management of PAT, which is essential for PAT method development and validation, ensuring ongoing performance evaluation throughout the application's life cycle. Detail continuous monitoring and assessment of PAT method performance, with a robust plan for monitoring, analyzing, and adjusting the method. The life cycle approach is crucial, as PAT method risk assessment must consider the product life cycle stage and data usage to maintain quality consistency throughout the product life cycle.

5. Present an overview of the regulatory landscape, highlighting how PAT aligns with current guidelines and standards. This section will discuss the implications of PAT on regulatory submissions and compliance.

6. Review emerging trends and technologies in PAT, discussing potential future directions and innovations in the field.

 (GCCA: Y. Liu)

 Case ID—SUB-988