A global manufacturer of large-scale anticoccidial drugs and traditional Chinese veterinary medicines.

Guangdong Kerun Biopharmaceutical Co., Ltd. was established in 2009 and is a national high-tech enterprise integrating bioengineering, pharmaceutical manufacturing, ecological cultivation and animal husbandry, as well as nutritional research and technological collaboration. The company has successfully passed audits and inspections by authoritative agencies including China’s Ministry of Agriculture and Rural Affairs, Australia’s APVMA, and regulatory bodies in Europe and the United States, and has been awarded designations such as “Guangdong Provincial Postdoctoral Workstation,” “Guangdong Provincial Science and Technology Expert Workstation,” “Guangdong Provincial Engineering Technology Research Center for Traditional Chinese Veterinary Medicinal Preparations,” “Guangdong Provincial Specialized, Refined, Distinctive, and Innovative SME,” “Guangdong Provincial Science and Technology‑Based SME,” and “Guangdong Provincial Innovative SME.”

A global manufacturer of large-scale anticoccidial drugs and traditional Chinese veterinary medicines.

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祝贺广东科润生物制药有限公司顺利通过新版兽药GMP认证

2022-05-27

2022年4月23日-24日，根据《兽药生产质量管理规范》（2020年修订）的规定，依照《兽药生产质量管理规范检查验收办法》，广东省农业农村厅派出专家组对广东科润生物制药有限公司实施GMP的情况进行现场检查验收。清远市农业农村局相关负责人作为观察员，参加了此次验收。

GMP验收专家组在听取了公司质量部经理对GMP实施情况的汇报后，对仓库、生产车间、厂房、质检中心等硬件设施、设备，质量控制保证、人员现场操作以及安全生产等方面进行了严格、细致、全面的检查与考核。随后，专家组认真查阅了GMP管理文件和各类档案资料，尤其重视风险管理、偏差、变更、质量回顾、风险评估等内容审查，并对员工兽药GMP知识掌握情况现场提问、考核。

专家组经过现场检查、材料审核等程序后，一致认为，广东科润生物制药有限公司能够严格按照GMP标准组织生产，人员和组织机构健全，职能明确，人员结构、素质和培训情况适应生产的需要，生产设备、检查设施等能够满足生产、检验需要，生产管理和质量管理符合新版兽药GMP规范。专家组对公司软硬件设备、管理水平、人员专业性给予了高度评价，宣布广东科润生物制药有限公司通过新版兽药GMP验收，并推荐粉剂/预混剂生产线为兽药GMP合格生产线。