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IKSA experts visited Minhai Biotechnology to assess the operation of its quality management system.

Release date:

2019-03-29

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Abstract

From March 18 to 22, 2019, a three-member IKSA expert team visited Minhai to assess the operation of its quality management system. Minhai’s General Manager Zheng Haifa, Executive Deputy General Manager Liu Jiankai, Vice President of Quality Li Xiangqun, Vice President of Production Nie Xiaoqi, and other relevant department heads extended a warm welcome to the IKSA experts.

　　Zhang Qian from Minhai’s International Cooperation Department presented an overview of the company to the IKSA expert panel. Subsequently, using the Hib conjugate vaccine as a case study, the panel divided into three groups—Quality Assurance, Quality Control, and the Manufacturing Workshop (including the Hib production unit, the secondary packaging unit, and the Engineering and Equipment Department)—to conduct an analysis of the gaps between the company’s quality system and WHO requirements.

　　After five days of rigorous inspection, the IKSA expert panel issued a truthful, detailed, and comprehensive analysis and summary report on the operation of our company’s quality management system. The report provided valuable recommendations to help us achieve WHO pre‑qualification in the future, while also setting higher and more stringent requirements for our quality assurance system. Company leadership stated that we must, in strict accordance with WHO standards, strengthen our quality awareness and enhance our quality management system to ensure product quality in a thorough and systematic manner.

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