新版兽药GMP检查常见问题分析及改进建议  

Analysis of Common Problems in the Inspection of the New Version of Veterinary Drug GMP and Suggestions for Improvement

作　　者：杨志昆 王艳玲 章安源 李有志 尹伶灵 门晓冬 冯涛 陈志强 陈玲[1] YANG Zhi-kun;WANG Yan-ling;ZHANG An-yuan;LI You-zhi;Yin Ling-ling;MEI Xiao-dong;FENG Tao;CHEN Zhi-qiang;CHEN Ling(Shandong provincial Feed and Veterinary Drug Quality Inspection Center,Jinan 250022,China;Qingdao VLAND Biological Inc,Qingdao,266000,China)

机构地区：[1]山东省饲料兽药质量检验中心,济南250022 [2]青岛蔚蓝生物股份有限公司,山东青岛266000

出　　处：《中国兽药杂志》2023年第1期52-57,共6页Chinese Journal of Veterinary Drug

摘　　要：自2020年6月实施新版兽药GMP验收标准以来,对山东省验收兽药企业中发现的常见缺陷项,从质量管理、机构人员、厂房与设施、设备、物料与产品、确认与验证、文件管理、生产管理、质量控制与质量保证、产品销售与召回、自检共11个部分给予总结和归纳,对问题产生原因进行了分析,并提出改进建议,以期为兽药生产企业更好地实施GMP工作提供借鉴和参考。Since June 2020, The new edition veterinary drug GMP standard has been implemented. The author summarized 11 common defects found in the acceptance of veterinary drug enterprises in Shandong Province including quality management、institutional personnel、plants and facilities equipment、materials and products、confirmation and verification、document management production management、quality control and quality assurance、product sales and recall、and self-inspection. Suggestions for improvement are forward to provide references for veterinary drug manufacturers to better implement GMP.

关 键 词：兽药生产质量管理规范 新版兽药GMP 检查验收 评定标准 

分 类 号：S851.66[农业科学—预防兽医学]