首页|关于兽药生产企业执行GMP过程中质量管理薄弱环节的几点思考

关于兽药生产企业执行GMP过程中质量管理薄弱环节的几点思考

扫码查看
本文从质量管理理念的发展与新版兽药GMP要求出发,剖析了目前兽药生产企业在质量管理理念、质量管理和质量控制力量及水平、GMP管理文件的执行、风险意识等方面的问题,提出了兽药生产企业应从强化质量管理理念、重视发挥QA和QC的作用、针对新版GMP要点和难点切实开展工作和真正建立风险管理机制方面切实采取措施,希望能借此帮助兽药生产企业完善质量管理,保证兽药GMP要求落实到位,推动兽药行业的高质量发展.
Weakness Analysis of Quality Management on the Implementation of GMP by Veterinary Drug Manufactures
Based on the quality management concept and requirements of the new version veterinary drug GMP,this article analyzed and identified problems on awareness of quality management,competency of quality management and quality contriol,implementation of the GMP files and risk perception,it is proposed that the manufactures should strengthen the quality management,further enhance QA and QC roles,take the effective measures according to the key and challenging points of the new version GMP,and set up the risk management mechanism.It is expected to support the industry to improve quality management,ensure the implementation of veterinary drug GMP requirements,and promote the high-quality development of the veterinary drug industry.

veterinary drugquality managementweaknessmeasures

张秀英、顾进华、陈莎莎、赵晖、杨秀玉、陈先国

展开 >

中国兽医药品监察所(农业农村部兽药评审中心),北京 100081

兽药 质量管理 薄弱环节 措施

国家重点研发计划国家重点研发计划

2022YFD18021002022YFD1802105

2024

中国兽药杂志
中国兽医药品监察所

中国兽药杂志

CSTPCD
影响因子:0.49
ISSN:1002-1280
年,卷(期):2024.58(3)
  • 1
  • 15