T/SHPPA 027-2024 Active

Scope: This document specifies the relevant requirements for the use of digital twin technology in the advanced manufacturing of pharmaceuticals, including system architecture, system construction elements, functional requirements, safety requirements, etc. This document is applicable to the design and practice of digital twin-related activities in the field of advanced pharmaceutical manufacturing. Main technical content: This document combines the Quality by Design (QbD) concept to propose the relevant requirements for the use of digital twin technology in the advanced manufacturing of pharmaceuticals. By simulating and optimizing the production line in terms of process yield, robustness, and asset utilization, it clarifies the goals and value, guides the industry to adopt automated technical means such as process analysis, improves production efficiency, reduces variability, shortens production cycles, enhances product quality controllability, monitors timeliness, provides patients with safer and more effective drugs, and further promotes the high-quality development of the biomedical industry.