News
Wanbande Pharmaceutical’s two production lines have passed GMP certification.
Date:
01 Mar,2021
On November 8, Wanbangde Pharmaceutical announced exciting news: following a rigorous on-site inspection by the Zhejiang Provincial Food and Drug Administration, the company’s two small-volume injectable (non-final sterilization) production lines in Area A of Workshop No. 2 successfully passed GMP certification, earning the national GMP certificate for pharmaceutical manufacturing. This milestone marks a significant leap forward in Wanbangde Pharmaceutical’s sterile preparation production technology, as well as its quality control and assurance systems—and it also lays a solid foundation for the company’s expansion into the broader healthcare industry.
The GMP certification audit took place from September 27 to September 30, during which a five-member inspection team from the Zhejiang Provincial Food and Drug Administration conducted an on-site review of the production and quality management practices at Area A of Workshop No. 2 for Small-Volume Injectable Products at Wanbangde Pharmaceutical. Over the four-day inspection, the expert team carefully listened to the report presented by Lin Hong, Deputy General Manager of the company. They rigorously assessed dozens of critical processes across the company’s production facilities—including hardware and software components such as the water preparation and utility systems, quality control laboratories, and warehouse centers—as well as areas like quality management, quality assurance, materials and product handling, documentation, self-inspection procedures, product distribution and recall protocols, and overall production and facility operations. The team also engaged in thorough discussions and exchanges with key representatives from each department. Ultimately, after comprehensive deliberation, the expert panel concluded that both production lines for small-volume non-final sterilized injectables fully comply with pharmaceutical GMP standards, officially certifying that the company has successfully passed the GMP on-site inspection.
This GMP certification covers two small-volume injectable (non-final sterilization) production lines, which primarily manufacture 40 different product specifications of small-volume injectables, including Huperzine A Injection and Ribavirin Injection. The successful completion of the GMP certification has significantly enhanced both the company’s product quality and economic efficiency, while also markedly strengthening its competitive edge.
Moving forward, Wanbangde Pharmaceutical will use certification as a fresh starting point for quality management, continuously refining and enhancing its quality system. The company will strengthen control over both internal and external key quality factors, ensuring scientific, comprehensive management and rigorous monitoring throughout the entire pharmaceutical production process. This approach aims to elevate product quality to leading global standards and align its quality management practices with international benchmarks. At the same time, the company will accelerate its strategic restructuring and transformation, focusing on cutting-edge, internationally advanced technologies to expedite the entry of its pharmaceutical products into mainstream markets in Europe and North America.
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