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Harwars successfully passed the GCP qualification certification of veterinary biological products

2022-11-09 15:30:19 admin 119

On February 17, the Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs issued the Notice on the Results of the Supervision and Inspection of Veterinary Drug Clinical Trial Quality Management Practice (Batch 22), confirming that Qingdao Haihua Biomedical Technology Co., Ltd. has obtained the GCP qualification certification of veterinary biological products for veterinary drug clinical trial quality management practice.

Previously, experts from the China Institute of Veterinary Drug Supervision, Shandong Animal Husbandry and Veterinary Bureau and Qingdao Animal Husbandry and Veterinary Bureau formed a veterinary drug GCP review expert group to conduct an on-site review of Haihua Biotechnology.

Harwars Biology Group

During the inspection and review, the expert group inspected the institutional setup, construction and operation of experimental facilities of Hihua Biotechnology, checked in detail the SOP and test records, personnel situation, quality assurance system and other archival materials of the declared project, tested the experimental operation skills of the experimenters on the spot, and had face-to-face discussions with the project leader and the main clinical trial technicians.

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The acquisition of the GCP qualification of veterinary drugs marks that Haihua Biotech has become a nationally recognized veterinary drug clinical trial unit with qualified qualifications. In the future, Haihua Biotech will continue to consolidate the service foundation, strengthen service awareness based on rigorous scientific research capabilities, implement and promote experiments in strict accordance with the GCP of veterinary drugs, drive the benign development of veterinary drug research and development in the industry, escort animal health, and contribute to the development of health undertakings.

Good Clinical Trial Practice (GCP): It is a standard for the whole process of clinical trials formulated in accordance with the Drug Administration Law of the People's Republic of China and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, including program design, organization and implementation, inspection and supervision, recording, analysis summary and report.

Good Clinical Trial Management Practice for Veterinary Drugs (GCP): In order to standardize the clinical trial process of veterinary drugs and ensure the authenticity, completeness and accuracy of test data, the standard provisions for the whole process of veterinary drug clinical trials formulated in accordance with the Regulations on the Administration of Veterinary Drugs, including program design, organization and implementation, inspection and supervision, recording, analysis summary and reporting.