《兽药生产质量管理规范(2020年修订)》的主要变化及实施建议

Main changes and implementation suggestions of Good manufacturing practice for veterinary drug(the 2020 verision)

《兽药生产质量管理规范(2020年修订)》为我国历次《兽药生产质量管理规范》修改幅度较大的一次,从条款、文字、篇章结构上均有较大的变化,总体内容更科学、更易于操作、更具有指导性。笔者通过对新发布的《兽药生产质量管理规范(2020年修订)》与2002年版《兽药生产质量管理规范》进行对比分析,梳理出《兽药生产质量管理规范(2020年修订)》引入风险管理和变更控制概念、提高了部分硬件设施要求、提升并细化软件管理等八方面的主要变化及重要措施,并对企业提出加强《兽药生产质量管理规范(2020年修订)》的学习、科学合理改造硬件设施、加快软件升级、积极有效推进《兽药生产质量管理规范(2020年修订)》的实施的建议,为兽药生产企业理解和实施《兽药生产质量管理规范(2020年修订)》提供参考。

Good manufacturing practice for veterinary drug(the 2020 verision)is the more modified revision of the previous Good manufacturing practice for veterinary drug in China.There are great changes in terms of terms,text and chapter structure,and the overall content is more scientific,easier to operate and more instructive.Through comparative analysis of the newly released of Good manufacturing practice for veterinary drug(the 2020 version)and the 2002 version of Good manufacturing practice for veterinary drug,the author sorted out the concept of risk management and change control introduced,raised the requirement of some hardware facilities,upgraded and refined the software management and other aspects of the main changes and important measures in Good manufacturing practice for veterinary drug(the 2020 version).Suggestions were put forward for enterprises to strengthen the study of Good manufacturing practice for veterinary drug(the 2020 version),scientifically and rationally transform the hardware facilities,speed up the software upgrade,and actively and effectively promote the implementation of Good manufacturing practice for veterinary drug(the 2020 version)which provided reference for the understanding and implementation of Good manufacturing practice for veterinary drug(the 2020 version)for the manufacturers of veterinary drugs.