FDA-Compliant Over 10-Billion-Tablet OSD Intelligent Manufacturing Project

• A state-level innovative group company that integrates R&D, production and sales of innovative drugs with a market value of RMB 73.919 billion. Publicly listed in Hong Kong, it ranks in the top 5 in Chinese pharmaceutical industry with 10+ drug manufacturing bases and 30+ subsidiaries. • It was planned to be the first intelligent OSD manufacturing project with an annual production capacity of over ten billions of tablets in China. The client required to realize a digital, less-manned and paperless operation for achieving the internationally first-class level and complying with the US FDA cGMP requirements.

AUSTAR Solution

• Digitalization consulting and simulation, to optimize the product design by data. - Simulated calculation (covering the production system and logistics system) - Research on digital blueprint design for the entire factory (production, warehouse and quality management information systems and IT network architecture) - Process flow (analysis and optimization) - Material scanning, identification and information tracing (material tracing system) • Design optimization of the overall process flow and layout, materials transfer planning and design, integration of MES and materials management and control system, and realizing of unmanned production with supporting of advanced materials transfer, weighing and transportation equipment. • Computerized system validation and compliance consultation complying with ISPE GAMP 5 (Version 2).

AUSTAR Value & Client Benefits

• With globally high-quality resources, the digitalization consulting and simulation AUSTAR delivered was in compliance with the US FDA cGMP requirements. The integrated solution of computerized system validation and compliance consultation made achieving the internationally first-class level realized. • Automatic weighing and dispensing, unmanned production and other advanced manufacturing methods were introduced. New technologies including AI, Internet +, big data analysis were applied in informatization systems (MCS, RCS, etc.), which deeply connected human-machine collaboration, automation, AI and Industrial Internet of Things with the pharmaceutical technologies to actualize the digital and unmanned operation of the whole production process. • The factory turned to be a digitalized center with a lower cost, better quality, higher operation efficiency, less-manned and paperless operation. 80% in efficiency improvement and 30% in cost saving were gained for this ultra-large-scale base.

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