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Corporate Announcement

Shijiazhuang No.4 Pharmaceutical and Guangxiang Pharmaceutical have both been recognized as quality benchmarks for industrial enterprises in Hebei Province.

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Corporate Announcement

Time:2022-01-20

【概要描述】 On December 8, the Department of Industry and Information Technology of Hebei Province released a notice announcing the list of quality benchmarks for industrial enterprises in the province for 2021. After recommendations from municipal bureaus across Hebei Province, expert reviews, and public announcements, “The Experience of Implementing Quality and Safety Management Throughout the Entire Lifecycle of Pharmaceuticals” by Shijiazhuang Sihua Pharmaceutical Co., Ltd. and “The Experience of Using Micro-Reaction Continuous Synthesis Technology to Control Residual Solvent Quality in Drug Manufacturing” by the Group’s Hebei Guangxiang Pharmaceutical Co., Ltd. were designated as the 2021 quality benchmarks for industrial enterprises in Hebei Province.

On December 8, the Department of Industry and Information Technology of Hebei Province released a notice announcing the list of quality benchmarks for industrial enterprises in the province for 2021. After recommendations from municipal bureaus across Hebei Province, expert reviews, and public announcements, “The Experience of Implementing Quality and Safety Management Throughout the Entire Lifecycle of Pharmaceuticals” by Shijiazhuang Sihua Pharmaceutical Co., Ltd. and “The Experience of Using Micro-Reaction Continuous Synthesis Technology to Control Residual Solvent Quality in Drug Manufacturing” by the Group’s Hebei Guangxiang Pharmaceutical Co., Ltd. were designated as the 2021 Hebei Provincial Quality Benchmarks for Industrial Enterprises.

Shijiazhuang Sihua Pharmaceutical Group is a large, high-tech pharmaceutical enterprise that integrates the R&D and industrialization of innovative drugs, generic drugs, specialty active pharmaceutical ingredients, high-end formulations, and pharmaceutical packaging materials. The company consistently upholds the goal of revitalizing China’s national pharmaceutical industry, dedicating itself to exploring more scientific approaches to ensure drug quality and safety, standardizing production processes and procedures, and nipping quality and safety risks in the bud—thereby producing high-quality, safe, effective, and reliably controlled pharmaceutical products for the people.

Shijiazhuang Fourth Pharmaceutical has established management standards—including GMP, GCP, and GLP—centered on quality and safety management throughout the entire lifecycle of pharmaceutical products. It has refined and deepened its comprehensive quality management system, introduced advanced production technologies such as flexible packaging for intravenous solutions, pioneered the one-step polypropylene bottle (stand-up pouch) manufacturing process, and developed and led industry adoption of negative-ion air-cleaning technology. The company is vigorously promoting intelligent manufacturing, advancing the deep integration of informatization and industrialization, and actively deploying and popularizing intelligent manufacturing equipment—including fully automatic light inspection machines, parallel robots, and smart logistics and warehousing systems—as well as laboratory LIMS & LES systems. These efforts ensure the safety and integrity of the systems. Shijiazhuang Fourth Pharmaceutical has also established a drug marketing risk management plan, improved its pharmacovigilance system, and built a robust sales and marketing service team. After years of continuous refinement, the company has gradually established and perfected an effective pharmaceutical quality and safety management system covering injection development, production management, and post-marketing services. As a result, it has achieved remarkable success and economic benefits in further reducing adverse reactions and improving key product quality indicators for its injectable products. Today, Shijiazhuang Fourth Pharmaceutical has become one of the fastest-growing pharmaceutical enterprises 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.”

Focusing on the critical quality parameter of “residual solvents,” Guangxiang Pharmaceutical Group has implemented improvements to its processes and deepened its refined production quality management practices. By introducing advanced equipment and process technologies, including microreactor continuous synthesis technology, the group has systematically studied and optimized each stage of the entire manufacturing process that affects product quality indicators. At the same time, it has leveraged new smart manufacturing technologies to establish correlations among various process parameters throughout the entire production cycle, thereby creating an automated information feedback management system that ensures optimal product quality. The group has explored and established an effective quality control system for residual solvents in active pharmaceutical ingredient (API) production, achieving remarkable results in further reducing key quality indicators such as residual solvents. The company has successively obtained national GMP certification as well as international certifications including BRC, FSSC22000, KOSHER, and HALAL. It has also set up provincial-level engineering research centers and provincial-level technology innovation centers as platforms for innovative quality control research. In 2021, the company was recognized as a provincial-level specialized, sophisticated, and new enterprise. As a result, its quality management and control capabilities have placed it among the leading enterprises nationwide, making it one of the industry’s benchmark companies in terms of quality.

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