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Qizheng Gannan Foge Tibetan Medicine Company successfully passed the third on-site GMP certification and license renewal review.
Release time:
2010-11-01 14:02
From September 12 to 13, a team of GMP certification experts from the Gansu Provincial Administration for Market Regulation of Food and Drugs, accompanied by leaders from the prefectural drug administration bureau, conducted a two-day on-site inspection, acceptance, and license renewal process for Qizheng Company’s Gannan Foge Pharmaceutical Factory as part of its third GMP re-certification.
To ensure the smooth completion of this GMP re-certification process, the leadership attached great importance to the effort and established a special GMP Certification Leading Group. In accordance with current pharmaceutical GMP requirements, the group systematically planned and arranged verification activities as well as software and hardware improvement measures. During this period, Gongbu Dongzhi, General Manager of Gannan Foge Company, convened numerous meetings to coordinate and implement the certification work. Each department conscientiously adhered to the principle of "the person in charge is responsible," carefully reviewing and preparing for the implementation of the relevant criteria, ensuring clear division of labor and well-defined responsibilities, thereby effectively guaranteeing the successful completion of this certification. Meanwhile, in multiple areas—including quality management organizations and personnel, plant buildings and facilities, equipment, materials, sanitation, validation, documentation, production management, quality control, sales and recall, complaints, and self-inspection—documents were systematically organized, revised, and improved in line with current pharmaceutical GMP requirements. As a result, the company’s production and quality management documents have become more systematic, dynamic, applicable, and traceable, and practical operational skills training emphasizing essential knowledge and competencies has been strengthened. Furthermore, the company made varying degrees of improvements to the hardware conditions of its Production Department and Quality Control Department, adding new production equipment and inspection instruments and facilities. These efforts have provided reliable support across all aspects, ensuring the smooth attainment of pharmaceutical GMP certification.
During the two-day on-site inspection, the expert panel conducted a thorough and meticulous item-by-item review of every stage of Foge Company’s operations, in strict accordance with GMP standards. In the end, all the items required for our company’s GMP re-certification met the GMP standards, and we successfully passed the third GMP certification on-site inspection and the license renewal review.
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