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Cherish Life, Care for Life, Create Life |
Superior quality represents 3SBio’s solemn commitment to patients and constitutes the pivotal foundation for fulfilling our mission of “making innovative biologics accessible to all.” We have upheld pharmaceutical quality and safety as our inviolable baseline. Through production management and quality assurance systems that comply with Chinese and international standards, we exercise meticulous oversight of every stage from raw materials to finished products, thereby providing patients with safe, high-quality, and accessible healthcare products.
We implement unified quality management standards, under the framework of which each production base formulates and implements detailed operating procedures and management protocols to ensure standardized and systematic quality management.
We have established a full-lifecycle quality management system spanning raw material procurement, drug R&D, production, testing, release, distribution, and recall. Through production process controls, critical in-process control, and online automated inspection systems, we ensure that the production process is continuously monitored. We have formulated a dedicated management protocol for contract manufacturing to ensure compliance with pharmaceutical laws, regulations, and technical specifications. At each production base, we conduct simulated product recall exercises every two to three years to ensure the effective operation of the traceability system.
All of our pharmaceutical subsidiaries have passed GMP certification, and multiple production sites have passed inspections and obtained certifications from regulatory authorities in PIC/S member countries. All of our production bases that have commenced operation and are in stable operation have secured relevant quality management system certifications.
Each production base has continuously improved the documentation of its quality management system, covering multiple dimensions such as laboratory management, product quality, risk and deviation management, and supplier and external management. Meanwhile, quarterly quality management reviews, annual self-inspections, and unscheduled internal quality audits are routinely carried out to ensure the effective operation and continuous improvement of the quality system.
Each production base is equipped with a comprehensive inspection management system, whereby products may only be released from the factory after undergoing internal quality inspection and review and receiving sign-off from the Qualified Person. Additionally, each production base is equipped to perform testing at every stage, from the receipt of materials to the release of finished products. 3SBio Shenyang, for example, boasts full-chain analytical testing capabilities for recombinant protein biologics. Sunshine Guojian holds metrology accreditation as an inspection and testing institution certified by the National Institutes for Food and Drug Control. Sciprogen Bio-pharmaceutical maintains multi-platform testing capabilities for recombinant protein biologics and small-molecule chemical drugs.
Each production base has established an employee quality training system to provide product quality and safety training to all employees at least once per year, thereby continuously enhancing employees’ quality awareness and operational capabilities.
Pharmacovigilance and risk management constitute essential components of the full-lifecycle drug management system. In accordance with laws and regulations such as the Drug Administration Law of the People’s Republic of China, the Administrative Measures for Adverse Drug Reaction Reporting and Monitoring, and the Good Pharmacovigilance Practices, 3SBio has established a pharmacovigilance system covering the entire lifecycle from new drug R&D to post-marketing surveillance. Each marketing authorization holder has established a Drug Safety Committee and an independent pharmacovigilance department encompassing three core functions: pharmacovigilance operations, pharmacovigilance training, and drug safety monitoring. 3SBio has also established effective and accessible channels for collecting post-marketing adverse drug reaction information and relies on its pharmacovigilance database to carry out data entry, quality control, and medical assessment. The post-marketing signal detection process follows the internationally recognized practice of “signal detection—signal validation—signal prioritization—signal assessment—risk stratification—recommended actions,” which continuously enhances the scientific rigor of signal detection and management compliance.