中国兽药杂志2024,Vol.58Issue(3) :24-29.DOI:10.11751/ISSN.1002-1280.2024.03.04

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

Weakness Analysis of Quality Management on the Implementation of GMP by Veterinary Drug Manufactures

张秀英 顾进华 陈莎莎 赵晖 杨秀玉 陈先国
中国兽药杂志2024,Vol.58Issue(3) :24-29.DOI:10.11751/ISSN.1002-1280.2024.03.04

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

Weakness Analysis of Quality Management on the Implementation of GMP by Veterinary Drug Manufactures

张秀英 1顾进华 1陈莎莎 1赵晖 1杨秀玉 1陈先国1
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作者信息

  • 1. 中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
  • 折叠

摘要

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.

Abstract

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.

关键词

兽药/质量管理/薄弱环节/措施

Key words

veterinary drug/quality management/weakness/measures

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基金项目

国家重点研发计划(2022YFD1802100)

国家重点研发计划(2022YFD1802105)

出版年

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
浏览量1
参考文献量15
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