2019-09-09
From September 4th to 6th, a four-member
expert team for the veterinary drug GCP (Good Clinical Practice) supervision
and inspection visited the animal health product factory of Guangdong Wens
Foodstuff Dahuanong Biotechnology Co., Ltd. (hereinafter referred to as Dahuanong
Animal Health Products Factory) to conduct a GCP supervision and inspection of
veterinary drugs. The expert team, in accordance with the "Veterinary Drug
Clinical Trial Quality Management Standards" and other relevant inspection
methods and standards, carried out a comprehensive inspection of the
implementation of veterinary drug GCP at Dahuanong Animal Health Products
Factory.
After thorough discussion, the expert group
unanimously agreed that the GCP organization of the Dahuanong Animal Health
Products Factory has a reasonable department structure, clear division of labor
among personnel, and complete facilities and equipment. The established
management system complies with the requirements of the "Veterinary Drug
Clinical Trial Quality Management Standards," and is capable of conducting
standardized veterinary drug clinical trials, including pig residue depletion
tests and pig pharmacokinetic trials.
It is reported that in order to further
strengthen the quality evaluation of veterinary drugs and ensure their safety
and efficacy, the Ministry of Agriculture and Rural Affairs issued relevant
management systems for veterinary drug GCP in December 2015 to regulate the
process of veterinary drug clinical trials. The Dahuanong Business Division
actively responded and made every effort to prepare for the GCP work. At the
beginning of this year, Zhaoqing Dahuanong Company passed the GCP supervision
and inspection for veterinary biological products, and now it has passed the
GCP supervision and inspection for veterinary chemical drugs. This is the
result of the division's long-term emphasis on scientific research investment
and will further standardize the company's veterinary drug clinical trial
process, improve the quality of veterinary drug clinical trials, and enhance
the company's research and development level of veterinary drugs.
(Dahuanong Business Division / Chemical
Pharmaceutical Company Wu Xueyu)