Traceability of the entire pharmaceutical production process is an important means to ensure pharmaceutical quality. In August 2023, the local standard "Construction and Operation Specifications for Digital Traceability System for the Whole Process of Drug Production" (DB31/T 1400-2012) drafted by the Shanghai Municipal Food and Drug Administration, Shanghai Pharmaceutical Quality Association and Shanghai Pharmaceutical Industry Association was officially Implementation, this standard also clarifies the construction of a digital traceability system covering the pharmaceutical production process to help enterprises promote digital development. In the same year, Rockwell joined hands with Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd. (referred to as "Daiichi Sankyo") to make a breakthrough attempt at advanced cloud deployment methods to create a full life cycle digital management and manufacturing management system (MES). 

Daiichi Sankyo is an original research-based multinational group with a history of more than 120 years. As early as the 1980s, Daiichi Sankyo began to introduce many excellent original research products into China and continued to expand its business in China. Now it has successfully established business organizations in China including R&D, production and sales.

Rockwell's mature pharmaceutical MES suite PharmaSuite helps Daiichi Sankyo achieve full life cycle traceability of materials and control of key production links; establish a new management model suitable for Daiichi Sankyo's development; and realize digitalization and refinement of production management. , production decisions are visualized and intelligent; it promotes enterprises to reduce costs and increase efficiency, and continuously improve industrial levels.

The quality of drugs needs to be reflected by design endowment, production process guarantee, and inspection results. Quality is not determined by inspection, but by design and production. Therefore, when drugs leave the factory, not only must the inspection results comply with regulations, but the production process must also comply with design and specification requirements. Rockwell uses the PharmaSuite MES system to provide Daiichi Sankyo with work order management, labeled material management and equipment management, and quality control of the production process. In the future, the system will automatically collect key operating parameters of the equipment and electronically record and efficiently collect the production process. data.

This project innovatively applies the industry's advanced cloud deployment method in Daiichi Sankyo, reducing enterprise deployment and debugging time, reducing operation and maintenance and hardware investment costs, and ensuring future scalability and continuous updates and upgrades.

Join hands with ecological partners to shape an intelligent future. As a leader in smart manufacturing, Rockwell Automation relies on its rich experience and advanced technology to empower the digital transformation of the biopharmaceutical industry and lead the infinite possibilities of the future.