Customer Audit Confirms Tsingke Manufacturing Systems and Controls
A customer quality audit at Tsingke's manufacturing facility focused on raw material traceability, equipment lifecycle management, and data integrity within its systems.
Tsingke, a synthetic biology company, recently hosted a customer quality audit at its Chengdu manufacturing facility, conducted by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. The audit focused on critical aspects including raw material traceability, equipment lifecycle management, computerized systems and data integrity, and biological sample management.
This examination underscores the importance of standardized manufacturing processes, reliable production data, and robust quality management systems as synthetic biology applications expand. The review detailed procedures for raw material receipt, inventory management, certificates of analysis (COA), and incoming material acceptance. It also verified the connections between raw materials, manufacturing activities, and finished products.
Equipment lifecycle management was assessed through qualification, calibration, and maintenance records. For computerized systems, validation documentation and access controls for systems like Core-System and U8 Cloud were reviewed. Procedures for data archiving, backup, and periodic review were also examined to ensure data integrity and availability.
Tsingke states that these quality systems and operational controls form the foundation for its "AI + Molecular Manufacturing" strategy. The company plans to further refine its manufacturing processes and quality systems, and explore the application of digital technologies and artificial intelligence in molecular manufacturing to enhance operational consistency and scalability.