2023-09-25
From September 19th to 21st, a team of three experts from the veterinary drug GCP supervision and inspection visited Guangdong Wens Food Dahuanong Biotechnology Co., Ltd. to conduct a three-day on-site supervision and inspection of the proposed expansion of swine efficacy evaluation tests and field trials for swine efficacy evaluation. Ultimately, the above two clinical trial projects that applied for expansion were successfully passed the inspection! As of now, the GCP institution of Guangdong Wens Food Dahuanong has had a total of 4 clinical trial projects that have passed the supervision and inspection by the Ministry of Agriculture and Rural Affairs.
The expert team, in accordance with the "Good Clinical Practice for Veterinary Drugs" and related inspection methods and standards, conducted a comprehensive inspection of the implementation of Guangdong Wens Food Dahuanong's veterinary drug GCP from two dimensions: software and hardware. This was done through listening to reports, inspecting the animal testing site, visiting the laboratory, on-site assessment of clinical trial techniques and sample testing capabilities, reviewing documents and records, and random questioning. After thorough discussion, the expert team unanimously believed that the various departments of the GCP institution of Guangdong Wens Food Dahuanong are reasonably set up, with clear division of labor among personnel, complete facilities and equipment, and a management system that complies with the requirements of the "Good Clinical Practice for Veterinary Drugs" and operates well. It is capable of conducting veterinary clinical trials in a standardized manner and has the capability to carry out swine efficacy evaluation tests and field trials for swine efficacy evaluation. At the same time, the supervision and inspection expert team also pointed out the existing problems and deficiencies of the institution and put forward rectification opinions and suggestions. The GCP institution of Guangdong Wens Food Dahuanong will earnestly implement the rectification opinions and suggestions put forward in this inspection, strengthen learning, continuously improve, and continuously enhance the management level and technical capabilities of the institution.
The supervision and inspection of the Ministry of Agriculture and Rural Affairs' veterinary drug GCP help to further standardize the operation of the Guangdong Wens Food Dahuanong veterinary drug GCP institution, improve the quality of clinical trials, and accelerate and enhance the development of new products.