Shijiazhuang Sihua Pharmaceutical and Guangxiang Pharmaceutical Both Recognized as Quality Benchmarks for Industrial Enterprises in Hebei Province


TIME:2022-01-20

【SUMMARY】 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 Microreaction 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 provincial industrial enterprise quality benchmarks. Following recommendations from municipal bureaus across Hebei Province, expert review, and public announcement, Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s “Experience in Implementing Quality and Safety Management Throughout the Entire Lifecycle of Pharmaceuticals” and Hebei Guangxiang Pharmaceutical Co., Ltd. of the Group’s “Experience in Applying Microreaction Continuous Synthesis Technology to Control Residual Solvent Levels in Pharmaceuticals for Quality Management” were designated as the 2021 Hebei Provincial Industrial Enterprise Quality Benchmarks.
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, nipping quality and safety risks in the bud, and 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 after-sales service. This has yielded significant results and economic benefits in further reducing adverse reactions associated with injectable products and improving key product quality indicators, positioning the company as one of the fastest-growing pharmaceutical enterprises in China. It 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 advanced 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 new smart manufacturing technologies to correlate and integrate process parameters across the entire production chain that influence product quality. 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) production, achieving significant reductions in key quality indicators such as residual solvents. The company has successively obtained national GMP certification as well as international certifications including 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 it as one of the industry’s benchmark enterprises for quality.

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