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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the development mode of “production, learning, research, and application” of multi-disciplinary integration and multi-directional combination.
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical and Guangxiang Pharmaceutical Both Recognized as Quality Benchmarks for Industrial Enterprises in Hebei Province
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发布时间：2022-01-20
【概要描述】
On December 8, the Hebei Provincial Department of Industry and Information Technology issued a notice on the 2021 List of Quality Benchmarks for Industrial Enterprises in the Province. Following recommendations from municipal bureaus across Hebei, expert review, and public announcement, Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s “Experience in Implementing Full-Life-Cycle Quality and Safety Management for Pharmaceuticals” and Hebei Guangxiang Pharmaceutical Co., Ltd. of the Group’s “Experience in Applying Micro-Reaction Continuous Synthesis Technology to Control Residual Solvent Levels in Pharmaceuticals for Quality Management” were designated as the 2021 Quality Benchmarks for Industrial Enterprises in Hebei Province.
On December 8, the Hebei Provincial Department of Industry and Information Technology issued a notice announcing the 2021 List of Quality Benchmarks for Industrial Enterprises in Hebei Province. Following recommendations from municipal bureaus across the province, expert review, and public announcement, Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s “Experience in Implementing Full-Life-Cycle Quality and Safety Management for Pharmaceuticals” and Hebei Guangxiang Pharmaceutical Co., Ltd. of the Group’s “Experience in Applying Micro-Reactor Continuous Synthesis Technology to Control Residual Solvent Levels in Pharmaceuticals for Quality Management” were designated as the 2021 Quality Benchmarks for Industrial Enterprises in Hebei Province.
Shijiazhuang Sihua Pharmaceutical Group is a large, high-tech pharmaceutical enterprise that pursues the coordinated development of innovative drugs, generic drugs, specialty APIs, high-end formulations, and pharmaceutical packaging materials through R&D and industrialization. The company remains steadfast in its commitment to revitalizing China’s national pharmaceutical industry, dedicated to exploring more scientifically sound approaches to ensure drug quality and safety, standardizing manufacturing processes and procedures, and nipping quality and safety risks in the bud—thereby producing safe, effective, and quality-controlled high-quality medicines for the general public.
Shijiazhuang Sihua Pharmaceutical has established management standards such as GMP, GCP, and GLP to ensure quality and safety throughout the entire lifecycle of pharmaceutical products. The company has refined and deepened its comprehensive quality management system, introduced innovative applications in flexible infusion packaging, pioneered the one-step polypropylene bottle-making (stand-up pouch) process, and developed and led industry adoption of negative-ion air purification technology for pharmaceutical manufacturing. It has vigorously promoted smart manufacturing, advanced the deep integration of informatization and industrialization, and deployed and scaled up intelligent manufacturing equipment—including fully automated visual inspection systems, parallel robots, and smart logistics and warehousing solutions—as well as laboratory LIMS and LES systems, thereby ensuring system security and integrity. The company has also formulated a post-marketing risk management plan, enhanced its pharmacovigilance system, and built a robust sales and market services team. After years of continuous refinement, it has gradually established and perfected an effective quality and safety management system covering injectable drug R&D, production management, and post-market customer service. This has yielded significant improvements in reducing adverse reactions associated with injectable products and enhancing key product quality indicators, resulting in notable economic benefits. As a result, Shijiazhuang Sihua Pharmaceutical has become one of the fastest-growing pharmaceutical companies in China and has been recognized as a “High-Tech Enterprise” and entrusted with the construction of the “National–Local Joint Engineering Laboratory for Quality Control of Chemical Injection Products.”
Guangxiang Pharmaceutical Group focuses on controlling the critical quality attribute of “residual solvents” by optimizing manufacturing processes, refining production quality management practices, introducing state-of-the-art equipment and process technologies, and implementing continuous microreactor synthesis. The company systematically identifies and upgrades process steps that impact product quality throughout the entire manufacturing cycle, while leveraging advanced smart manufacturing technologies to correlate and integrate key process parameters across the entire production chain. An automated information feedback management system has been established to ensure optimal product quality. Through extensive exploration and experimentation, the group has developed an effective quality control system for residual solvents in active pharmaceutical ingredient (API) manufacturing, achieving significant reductions in residual solvent levels and other critical quality metrics. The company has successively obtained national GMP certification as well as international certifications such as BRC, FSSC 22000, KOSHER, and HALAL. It has also established provincial-level engineering research centers and provincial-level technology innovation centers as platforms for innovative quality-control research. In 2021, it was recognized as a provincial-level specialized, refined, distinctive, and innovative enterprise, placing its quality management and control capabilities among the leading peers nationwide and establishing itself as a benchmark for quality in the industry.
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